Indicator, Biological Sterilization Process

FRC 2025-09-24

Celerity™ 20 HP Biological Indicator

Applicant STERIS Corporation

K number K252680

FRC 2025-08-04

Terragene® Bionova® BT20 Biological Indicator

Applicant Terragene

K number K251122

FRC 2025-06-06

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

Applicant Steris

K number K251452

FRC 2025-02-06

Celerity Incubator

Applicant STERIS Corporation

K number K250061

FRC 2025-02-06

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

Applicant STERIS Corporation

K number K250044

FRC 2025-01-28

3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M

Applicant 3M Company

K number K243501

FRC 2024-12-12

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

Applicant Terragene S.A.

K number K242453

FRC 2024-11-25

3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M

Applicant 3M Company

K number K242538

FRC 2024-10-18

3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)

Applicant 3M Company

K number K241959

FRC 2024-09-18

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

Applicant Terragene S.A.

K number K231383

FRC 2024-09-12

3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M

Applicant 3M Company

K number K241710

FRC 2024-06-27

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)

Applicant 3M Company

K number K241542

FRC 2024-06-27

3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Applicant 3M Company

K number K240717

FRC 2024-03-15

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)

Applicant 3M Company

K number K233814

FRC 2023-12-15

ConFirm 20 Minute Incubator

Applicant STERIS Corporation

K number K233681

FRC 2023-08-07

Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator

Applicant STERIS Corporation

K number K231490

FRC 2023-06-15

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack

Applicant STERIS Corporation

K number K223717

FRC 2023-06-15

Celerity Incubator

Applicant STERIS Corporation

K number K223715

FRC 2023-05-09

Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Applicant Plasmapp Co,., Ltd.

K number K223023

FRC 2023-02-28

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

Applicant Terragene S.A.

K number K221641

FRC 2022-07-21

Celerity Incubator

Applicant STERIS Corporation

K number K213881

FRC 2022-06-28

3M Attest Rapid Readout Biological Indicator, 1295

Applicant 3M Company

K number K211705

FRC 2022-04-12

Anprolene SteriTest RRBI

K number K213296

FRC 2022-04-06

3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader

Applicant 3M Company

K number K213809

FRC 2022-03-18

CELERITY 20 HP Challenge Pack

Applicant Steris

K number K220473

FRC 2021-10-22

Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Applicant Plasmapp Co,., Ltd.

K number K212193

FRC 2021-03-24

STERIZONE VP4 Test Pack

Applicant Tso3 Inc., Now A Part of Stryker

K number K203560

FRC 2021-03-03

3M Attest Rapid Readout Biological Indicator, 1295

Applicant 3M Company

K number K210277

FRC 2021-03-03

EOGas 4 Endo-SteriTest RRBI

K number K202879

FRC 2021-01-08

Celerity 20 Steam Biological Indicator for IUSS

Applicant STERIS Corporation

K number K202721

FRC 2020-12-28

Self-Contained Biological Indicator

Applicant True Indicating, LLC

K number K200970

FRC 2020-12-11

3M Attest Rapid Readout Biological Indicator

Applicant 3M Company

K number K200996

FRC 2020-11-12

EOGas 4 Endo-SteriTest

K number K192980

FRC 2020-07-02

3M Attest Steam Chemical Integrator Test Pack

Applicant 3M Company

K number K200766

FRC 2020-06-05

3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H

Applicant 3M Company

K number K192550

FRC 2020-06-01

3MTM AttestTM Rapid 5 Steam-Plus Test Pack

Applicant 3M Complany

K number K200536

FRC 2020-05-22

VERIFY Assert Self-Contained Biological Indicator

Applicant STERIS Corporation

K number K200126

FRC 2020-04-15

3MTM AttestTM Mini Auto-reader 490M

Applicant 3M

K number K200092

FRC 2020-02-07

3M Attest Super Rapid 5 Steam-Plus Challenge Pack

Applicant 3M Company

K number K193154

FRC 2020-01-23

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

Applicant Advanced Sterilization Products (Asp)

K number K192025

FRC 2019-10-22

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

Applicant Sterilucent, Inc.

K number K192001

FRC 2019-09-13

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

Applicant Terragene S.A.

K number K191021

FRC 2019-05-14

Celerity HP Incubator

Applicant STERIS Corporation

K number K190297

FRC 2019-01-03

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

Applicant Steris Corporations

K number K183300

FRC 2019-01-03

CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack

Applicant STERIS Corporation

K number K183294

FRC 2018-12-27

STERRAD VELOCITY Biological Indicator

Applicant Advanced Sterilization Products (Asp)

K number K182404

FRC 2018-11-20

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

Applicant Steris Corporations

K number K182931

FRC 2018-11-14

SporView Rapid Read Biological Indicator SteamPlus Test Pack

Applicant Crosstex/Spsmedical, A Division of Cantel Medical

K number K181434

FRC 2018-07-24

CELERITY 20 Steam Biological Indicator

Applicant STERIS Corporation

K number K181686

FRC 2018-06-13

CELERITY 20 HP Biological Indicator

Applicant STERIS Corporation

K number K181429

FRC 2018-04-23

3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader

Applicant 3M Company

K number K173519

FRC 2018-03-19

3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H

Applicant 3M Company

K number K173437

FRC 2018-03-01

CELERITY 20 HP Challenge Pack

Applicant STERIS Corporation

K number K173488

FRC 2018-02-28

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

Applicant STERIS Corporation

K number K173633

FRC 2018-02-21

CELERITY 20 Steam Process Challenge Device for Gravity Cycles

Applicant STERIS Corporation

K number K173629

FRC 2018-02-21

Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles

Applicant STERIS Corporation

K number K173626

FRC 2018-02-12

CELERITY 20 Steam Incubator

Applicant STERIS Corporation

K number K173670

FRC 2018-02-12

CELERITY 20 Steam Biological Indicator

Applicant STERIS Corporation

K number K173634

FRC 2018-02-09

3M Attest Rapid Readout Biological Indicator

Applicant 3M Company

K number K173435

FRC 2018-02-09

CELERITY 20 HP Biological Indicator

Applicant STERIS Corporation

K number K172752

FRC 2018-02-09

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

Applicant Steris Corporations

K number K172748

FRC 2018-02-01

Sporview VH202 BI

Applicant Spsmedical Supply Corp. A Division of Cantel Medical

K number K171287

FRC 2018-01-22

3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader

Applicant 3M Company

K number K173584

FRC 2017-12-29

Celerity 20 HP Biological Indicator

Applicant STERIS Corporation

K number K172474

FRC 2017-12-12

SporView Rapid Read Biological Indicator

Applicant Crosstex/Spsmedical, A Division of Cantel Medical

K number K172432

FRC 2017-11-02

Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator

Applicant Terragene S.A.

K number K163646

FRC 2017-10-31

Anprolene SteriTest

K number K170427

FRC 2017-08-22

VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator

Applicant STERIS Corporation

K number K171587

FRC 2017-08-22

VERIFY Assert VH2O2 Self-Contained Biological Indicator

Applicant STERIS Corporation

K number K171504

FRC 2017-07-21

3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader

Applicant 3M Company

K number K171003

FRC 2017-06-20

STERRAD VELOCITY Biological Indictator and Reader

Applicant Advanced Sterilization Products (Asp)

K number K170039

FRC 2017-04-28

VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles

Applicant STERIS Corporation

K number K170070

FRC 2017-04-07

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

Applicant Gke-GmbH

K number K163144

FRC 2016-06-09

3M Attest Rapid Readout Biological Indicator

Applicant 3M Company

K number K160546

FRC 2016-02-26

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

Applicant Bcr Diagnostics, Inc.

K number K151482

FRC 2013-11-26

SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR

Applicant Spsmedical Supply Corp.

K number K122024

FRC 2013-03-26

SMART-WELL INCUBATOR

Applicant Mesa Laboratories, Inc.

K number K122362

FRC 2013-03-18

3M ATTEST(TM) AUTO-READER

Applicant 3M Company

K number K123546

FRC 2013-03-15

3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK

Applicant 3M Company

K number K121593

FRC 2012-12-26

STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324

K number K123017

FRC 2012-10-19

3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER

Applicant 3M Company

K number K121484

FRC 2012-10-04

STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR

K number K122044

FRC 2012-09-26

STERRAD (R) 100NX DUO CYCLE TEST PACK

K number K111391

FRC 2012-09-14

STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR

K number K111375

FRC 2012-04-27

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS

Applicant North American Science Assoc., Inc.

K number K113221

FRC 2012-02-01

SPSMEDICAL SPORVIEW STEAM BI

Applicant Spsmedical Supply Corp.

K number K111515

FRC 2012-01-30

SMART READ EZTEST STEAM

Applicant Mesa Laboratories, Inc.

K number K112018

FRC 2012-01-20

NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS

Applicant North American Science Assoc., Inc.

K number K113302

FRC 2011-07-08

STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

Applicant Steritec Products Mfg Co, Inc.

K number K111150

FRC 2011-04-19

3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER

Applicant 3M Company-3M Health Care

K number K103277

FRC 2011-02-25

STERRAD CYCLESURE BIOLOGICAL INDICATOR

K number K103222

FRC 2011-02-25

STERRAAD 100NX EXPRESS CYCLE TEST PACK

K number K092755

FRC 2011-02-16

DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES

Applicant Dana Products, Inc.

K number K103321

FRC 2011-01-28

STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR

K number K102884

FRC 2010-12-08

3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS

Applicant 3M Company

K number K101910

FRC 2010-05-14

SMART-READ EZTEST-STEAM SCBI AND TEST PACK

Applicant Sgm Biotech, Inc.

K number K093794

FRC 2010-03-18

DANA REUSABLE TEST PACK FOR STEAM STERILIZATION

Applicant Dana Products, Inc.

K number K092944

FRC 2010-01-15

SMART-WELL EZTEST INCUBATOR

Applicant Sgm Biotech, Inc.

K number K091950

FRC 2009-12-30

VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION

Applicant STERIS Corporation

K number K092906