Spirometer, Therapeutic (Incentive)

FDA product code BWF · 104 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5690
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-06 – 2025-08-21

BWF 2025-08-21

InSee

Applicant Tidal Medical Technologies, LLC

K number K241152

View details →

BWF 2024-02-02

AllPEP

Applicant Enchant Tek Co. , Ltd.

K number K233855

View details →

BWF 2023-07-05

LungTrainer (MD2 & MD3)

Applicant Lung Trainers, LLC

K number K221058

View details →

BWF 2023-06-02

Breathe+

Applicant Peep Medical, LLC Dba Go2 Devices

K number K222018

View details →

BWF 2022-10-25

Hudson RCI Triflo II Incentive Deep Breathing Exerciser

Applicant Medline Industries, Inc.

K number K220565

View details →

BWF 2021-03-31

Pulsehaler

Applicant Respinova, Ltd.

K number K203378

View details →

BWF 2020-02-19

D R Burton OxyPAP

Applicant D R Burton Healthcare, LLC

K number K192000

View details →

BWF 2019-10-24

Acapella Choice Blue Vibratory PEP Device

Applicant Smiths Medical

K number K181660

View details →

BWF 2019-08-16

Combined Aerobika OPEP and VersaPAP device

Applicant Trudell Medical International

K number K183108

View details →

BWF 2019-07-01

Hudson RCI Voldyne Volumetric Exerciser

Applicant Teleflexmedical, Inc.

K number K182847

View details →

BWF 2018-08-17

VersaPAP Positive Airway Pressure (PAP) Device

Applicant Trudell Medical International

K number K173918

View details →

BWF 2017-12-22

VPOD ITPR

Applicant Advanced Circulatory System, A Wholly Owned Subsidiary OF

K number K172388

View details →

BWF 2017-02-23

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM

Applicant Medinet Srl

K number K160837

View details →

BWF 2017-02-21

VibraPEP

Applicant Medica Holdings, LLC

K number K163091

View details →

BWF 2016-08-03

iPEP System and vPEP

Applicant D R Burton Healthcare, LLC

K number K160636

View details →

BWF 2016-05-27

O-PEP

Applicant Pari Respiratory Equipment, Inc.

K number K150044

View details →

BWF 2016-03-25

VibraPEP

Applicant Medica Holdings, LLC

K number K153441

View details →

BWF 2013-05-16

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

Applicant Trudell Medical Intl.

K number K123400

View details →

BWF 2010-01-04

LUNG FLUTE THERAPEUTIC

Applicant Medical Acoustics

K number K091557

View details →

BWF 2009-07-21

PARI PEP S

Applicant Pari Respiratory Equipment, Inc.

K number K090829

View details →

BWF 2009-01-13

RESPIFIT S, MODEL RS-LR1001004

Applicant Eumedics Medizintechnik Und Marketing GmbH

K number K080299

View details →

BWF 2007-06-20

CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)

Applicant Advanced Circulatory Systems, Inc.

K number K070490

View details →

BWF 2005-12-13

SPIRO-BALL

Applicant Leventon, S.A.

K number K053149

View details →

BWF 2004-04-07

LIFESTYLE CIRCULATORY ENHANCER

Applicant Advanced Circulatory Systems, Inc.

K number K040084

View details →

BWF 2003-11-20

MODIFICATION TO RESQPOD CIRCULATORY ENHANCER

Applicant Advanced Circulatory Systems, Inc.

K number K033401

View details →

BWF 2003-06-11

RESQPOD CIRCULATORY ENHANCER

Applicant Cprx, LLC

K number K022906

View details →

BWF 2002-02-12

AEROPEP

Applicant Trudell Medical Intl.

K number K012368

View details →

BWF 2000-12-05

ACAPELLA

Applicant Dhd Healthcare Corp.

K number K002768

View details →

BWF 2000-11-21

CLINIFLO INCENTIVE SPIROMETER

Applicant Dhd Healthcare Corp.

K number K003146

View details →

BWF 2000-06-08

TRI-BALL

Applicant Leventon, S.A.

K number K994074

View details →

BWF 2000-04-12

INCENTIVE SPIROMETER

Applicant Engineered Medical Systems

K number K000314

View details →

BWF 2000-01-11

FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01

Applicant Intercontinental New Technologies, Inc.

K number K992256

View details →

BWF 1999-11-10

ROADRUNNER, PEP THERAPY DEVICE

Applicant Dhd Healthcare Corp.

K number K991561

View details →

BWF 1999-07-12

BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE

Applicant Dhd Healthcare Corp.

K number K991300

View details →

BWF 1999-06-04

RC CORNET, MODEL #44F50

Applicant Pari Holding Co.

K number K983308

View details →

BWF 1999-06-01

VITAL PEP

Applicant Vital Signs, Inc.

K number K984468

View details →

BWF 1999-04-02

THERAPEP

Applicant Dhd Healthcare Corp.

K number K983467

View details →

BWF 1998-08-06

MINI-CISER

Applicant Hougen Mfg., Inc.

K number K974848

View details →

BWF 1998-04-03

THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER

Applicant Pn Medical

K number K972824

View details →

BWF 1997-08-05

PARI PEP THERAPY SYSTEM

Applicant Pari Holding Co.

K number K972042

View details →

BWF 1997-05-16

DHD EMERALD PRODUCT

Applicant Dhd Diemolding Healthcare Div.

K number K970596

View details →

BWF 1996-10-21

MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX

Applicant Mercury Medical

K number K954492

View details →

BWF 1996-10-10

THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT

Applicant Diemolding Corp.

K number K962749

View details →

BWF 1996-07-15

PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE

Applicant Healthscan Products, Inc.

K number K961077

View details →

BWF 1996-02-08

MISTASSIST BREATHING EXERCISER

Applicant The Merlin Corp.

K number K953055

View details →

BWF 1995-04-26

THE BREATHER

Applicant Pal Medical, Inc.

K number K944412

View details →

BWF 1995-02-03

LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER

Applicant Lung Technologies, Inc.

K number K944344

View details →

BWF 1995-01-13

EXPIRATORY BREATHING EXERCISER

Applicant Dhd Diemolding Healthcare Div.

K number K945118

View details →

BWF 1995-01-06

THERAPEP

Applicant Dhd Diemolding Healthcare Div.

K number K944900

View details →

BWF 1994-09-19

MERCURY EXPIRATORY RESISTANCE EXERCISER

Applicant Mercury Ent., Inc. D/B/A Mercury Medical

K number K942919

View details →

BWF 1992-01-30

THRESHOLD 2X INSPIRATORY MUSCLE TRAINER

Applicant Health Products, Inc.

K number K912943

View details →

BWF 1991-03-12

TVS II ELECTRONIC INCENTIVE SPIROMETER

Applicant Monaghan Medical Corp.

K number K910138

View details →

BWF 1990-12-10

THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000

Applicant Pegasus Research Corp.

K number K903489

View details →

BWF 1990-03-15

RESPIREX 2

Applicant Diemolding Corp.

K number K900754

View details →

BWF 1989-08-21

AEROSOL INHALATION MONITOR

Applicant Vitalograph , Ltd.

K number K893665

View details →

BWF 1988-02-04

AEROBICA - LUNG EXERCISER

Applicant MBA Healthcare Products, Inc.

K number K873540

View details →

BWF 1987-12-30

AMBU RMT VALVE

Applicant Ambu, Inc.

K number K873579

View details →

BWF 1987-07-08

TOTAL LUNG EXERCISER (TLE)

Applicant MBA Healthcare Products, Inc.

K number K871904

View details →

BWF 1987-06-15

MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER

Applicant Health Products, Inc.

K number K871742

View details →

BWF 1987-03-31

THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER

Applicant Health Products, Inc.

K number K870514

View details →

BWF 1987-03-16

PFLEX EM(TM) (EXERCISE MONITOR)

Applicant Health Products, Inc.

K number K864719

View details →

BWF 1986-08-07

THE LUNG GYM (XLATOR AND NLATOR)

Applicant El-Fax Company, Inc.

K number K861564

View details →

BWF 1985-08-06

AIRLIFE ELECTRONIC INCENTIVE SPIROMETER

Applicant American Pharmaseal Div. Ahsc

K number K851334

View details →

BWF 1985-06-07

VITAPEP

Applicant Vitalograph , Ltd.

K number K844963

View details →

BWF 1984-08-27

ELECATH INFANT ARTERIAL & VENOUS CANNU

Applicant Electro-Catheter Corp.

K number K842369

View details →

BWF 1984-08-10

PFLEX RESPIRATORY MUSCLE EXERCISER

Applicant Health Scan, Inc.

K number K842634

View details →

BWF 1984-03-05

VOFLEX

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K840239

View details →

BWF 1984-02-17

INSPIRATORY/EXPIRATORY MUSCLE EXERCIS

Applicant Inspiron Corp.

K number K840418

View details →

BWF 1983-11-28

VOLUREX II

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K833337

View details →

BWF 1983-11-08

INSPIROMETER

Applicant Kinetix

K number K833012

View details →

BWF 1983-10-14

GOAL TENDER

Applicant Dna Medical, Inc.

K number K832878

View details →

BWF 1983-06-03

INSPIRATORY RESISTOR KIT

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K831142

View details →

BWF 1982-09-24

BE#6006 VAR. RESIS. INSPIR. MUSCLE

Applicant Instrumentation Industries, Inc.

K number K821492

View details →

BWF 1982-08-27

SPI-RISE

Applicant Certified Respiratory Services, Inc.

K number K822359

View details →

BWF 1982-07-30

RESPICORD

Applicant Novamed Products, Inc.

K number K821998

View details →

BWF 1982-03-26

PFLEX TM

Applicant Health Scan, Inc.

K number K820528

View details →

BWF 1982-03-23

MONAGHAN'S TRUE VOLUME EXERCISER

Applicant Monaghan Medical Corp.

K number K820606

View details →

BWF 1981-12-31

OHIO VOLUME INCENTIVE SPIROMETER

Applicant Airco/Ohio Medical Products

K number K813476

View details →

BWF 1981-05-13

K-MED ENCOURAGER INCENTIVE SPIROMETER

Applicant K-Med, Inc.

K number K810641

View details →

BWF 1980-06-04

VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX

Applicant Chesebrough-Pond'S U.S.A. Co.

K number K801199

View details →

BWF 1980-03-25

BUNN VOLUMAIRE RESPIRATORY EXERCISER

Applicant The John Bunn Co.

K number K800546

View details →

BWF 1980-02-28

ARGYLE TRU-VOL

Applicant Sherwood Medical Co.

K number K800386

View details →

BWF 1980-01-04

DISPOSABLE INCENTIVE SPIROMETER

Applicant Hospitak, Inc.

K number K792598

View details →

BWF 1979-12-19

COUNTER UNIT

Applicant Empire Plastics Manufacturer

K number K792571

View details →

BWF 1979-11-27

AIR INCENTIVE SPIROMETER, W/NEBULIZER

Applicant Airlife, Inc.

K number K792217

View details →

BWF 1979-11-27

MODEL TM2-BEHIND-THE-EAR TINNITUS

Applicant Starkey Laboratories, Inc.

K number K792214

View details →

BWF 1979-10-01

MOTIVATOR

Applicant Puritan Bennett Corp.

K number K791842

View details →

BWF 1979-09-26

AIR INCENTIVE SPIROMETER

Applicant Airlife, Inc.

K number K791819

View details →

BWF 1979-06-13

VOLUREX TM

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K791015

View details →

BWF 1979-04-27

LUNG FUNCTION AMPLIFIER EXERCISER

Applicant Empire Plastics Manufacturer

K number K790744

View details →

BWF 1978-12-15

SPIROMETER, INCENTIVE CATALOG # 1750

Applicant Hudson Oxygen Therapy Sales Co.

K number K781831

View details →

BWF 1978-12-13

SPIROCARE 108-B

Applicant Marion Laboratories, Inc.

K number K782016

View details →

BWF 1978-12-05

INCENT-O-NEB

Applicant B & F Medical Products, Inc.

K number K781731

View details →

BWF 1978-11-21

CALCULATOR, WITH CHARGER

Applicant C.R. Bard, Inc.

K number K781838

View details →

BWF 1978-11-14

EXERCISER, AIR-EZE INCENTIVE

Applicant Chesebrough-Pond'S U.S.A. Co.

K number K781833

View details →

BWF 1978-10-23

RESPIRATORY EXERCISOR, VOLUME PULSE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K781669

View details →

BWF 1978-09-20

LUNG EXER. BAG, POST-OP, MODIFIED

Applicant Dytek Corp.

K number K781245

View details →

BWF 1978-03-09

FLOW REDUCING ANGULATION STAND

Applicant Chesebrough-Pond'S U.S.A. Co.

K number K780265

View details →

BWF 1978-02-24

EXERCISER, RESP., DEEP BREATHING

Applicant Medical Technologies of Georgia

K number K780037

View details →

BWF 1977-08-26

SPIROMETEO & LUNG EXERCISER, 4601

Applicant Boehringer Laboratories

K number K771532

View details →