Nebulizer (Direct Patient Interface)

FDA product code CAF · 492 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5630
Review panel: AN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-20 – 2026-09-18

CAF 2000-10-13

AERONEB PORTABLE NEBULIZER

Applicant Aerogen, Inc.

K number K003022

View details →

CAF 2000-08-25

AERONEB II, MODEL APN 200

Applicant Aerogen, Inc.

K number K992831

View details →

CAF 2000-07-05

AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)

Applicant Trudell Medical Int'L

K number K001137

View details →

CAF 2000-06-16

CONTEMPRO-MIST

Applicant Contemporary Products, Inc.

K number K000543

View details →

CAF 2000-06-05

BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100

Applicant Apex Medical Corp.

K number K990435

View details →

CAF 2000-04-21

DEVILBISS NEBULIZER MODEL 800

Applicant Sunrise Medical Hhg, Inc.

K number K993492

View details →

CAF 2000-03-28

POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER

Applicant Ferraris Medical, Inc.

K number K993199

View details →

CAF 2000-03-22

SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896

Applicant Hudson Respiratory Care, Inc.

K number K994352

View details →

CAF 2000-03-15

NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER

Applicant Puritan-Bennett Ireland, Ltd.

K number K990897

View details →

CAF 2000-01-27

METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE

Applicant Instrumentation Industries, Inc.

K number K991355

View details →

CAF 2000-01-07

SALTER AIRE COMPRESSOR

Applicant Salter Labs

K number K992285

View details →

CAF 1999-11-12

EZFLOW MAX, MODEL 1007

Applicant Piper Medical Products

K number K993558

View details →

CAF 1999-11-10

PRIMEAIRE

Applicant Thayer Medical Corp.

K number K992722

View details →

CAF 1999-10-27

MODEL IRC 1001 AEROSOL COMPRESSOR

Applicant Invacare Corp.

K number K992643

View details →

CAF 1999-09-24

SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER

Applicant Salter Labs

K number K992986

View details →

CAF 1999-09-14

AEROCHAMBER PLUS VALVED HOLDING CHAMBER

Applicant Trudell Medical Int'L

K number K992917

View details →

CAF 1999-09-09

POCKETSPACER

Applicant Ferraris Medical, Inc.

K number K992038

View details →

CAF 1999-09-03

SHINMED MODEL SW-966 ULTRASONIC NEBULIZER

Applicant Shining World Health Care Co., Ltd.

K number K980024

View details →

CAF 1999-08-13

HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR

Applicant Medic-Aid , Ltd.

K number K991685

View details →

CAF 1999-08-06

SALTER LABS PEP DEVICE

Applicant Salter Labs

K number K991788

View details →

CAF 1999-08-05

RITEFLO SPACER

Applicant Aeromax Technologies, Inc.

K number K984085

View details →

CAF 1999-07-30

SIDESTREAM NEBULIZER

Applicant Inspired Medical Products , Ltd.

K number K991725

View details →

CAF 1999-04-26

EZFLOW CONTINUOUS NEBULIZER,MODEL 1005

Applicant Piper Medical Products

K number K990384

View details →

CAF 1999-04-12

AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD

Applicant Ambu, Inc.

K number K982722

View details →

CAF 1999-04-01

MDILOG, MODEL MDC-512

Applicant Medtrak Technologies, Inc.

K number K990185

View details →

CAF 1999-03-11

MABIS NB-02 ULTRASONIC NEBULIZER

Applicant Mabis Healthcare, Inc.

K number K990506

View details →

CAF 1999-01-08

TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER

Applicant Trudell Medical

K number K982181

View details →

CAF 1998-12-22

LS SERIES 200 FLOVISION SYSTEM

Applicant Systam

K number K971981

View details →

CAF 1998-12-17

SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER

Applicant Salter Labs

K number K983403

View details →

CAF 1998-11-23

METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D

Applicant Instrumentation Industries, Inc.

K number K981249

View details →

CAF 1998-11-10

ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER

Applicant Brasamerica Medical Equipment, Inc.

K number K983736

View details →

CAF 1998-11-09

BRENEB

Applicant Bremed Italia, S.R.L.

K number K982043

View details →

CAF 1998-11-03

HALOLITE AAD SYSTEM

Applicant Medic-Aid , Ltd.

K number K981772

View details →

CAF 1998-10-16

MYSTIQUE ULTRASONIC NEBULIZER

Applicant Airsep Corp.

K number K983002

View details →

CAF 1998-09-17

TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER

Applicant Trudell Medical

K number K982179

View details →

CAF 1998-09-14

AEROTEE, MODEL # 1001

Applicant Piper Medical Products

K number K982408

View details →

CAF 1998-08-24

BREATHERITE

Applicant Ventlab Corp.

K number K981944

View details →

CAF 1998-06-18

STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT

Applicant Dhd Healthcare Corp.

K number K981167

View details →

CAF 1998-06-12

56 SERIES AEROSOL GENERATOR

Applicant Project Marketing

K number K980074

View details →

CAF 1998-06-02

3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP

Applicant Steripak, Ltd.

K number K980829

View details →

CAF 1998-05-27

HOPE NEBULIZER

Applicant B&B Medical Technologies, Inc.

K number K980407

View details →

CAF 1998-03-19

STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR

Applicant Dhd Diemolding Healthcare Div.

K number K973532

View details →

CAF 1998-02-18

ULTRANEB

Applicant Bremed Italia, S.R.L.

K number K974379

View details →

CAF 1998-02-02

ULTRAMIST 2000

Applicant Texas Medical Industries, Inc.

K number K972657

View details →

CAF 1998-01-21

0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP

Applicant Holopack International, LP

K number K974056

View details →

CAF 1997-12-08

MODEL IRC 1199 SCOUT NEBULIZER

Applicant Invacare Corp.

K number K973468

View details →

CAF 1997-11-13

ATOMISOR

Applicant Medical Consulting Service, Inc.

K number K970844

View details →

CAF 1997-10-08

DEY VIAL SODIUM CHLORIDE 3%

Applicant Dey Laboratories, Inc.

K number K972778

View details →

CAF 1997-09-26

SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES

Applicant Monarch Medical

K number K971808

View details →

CAF 1997-08-28

STERILE WATER FOR INHALATION, USP

Applicant Holopack International, LP

K number K972467

View details →

CAF 1997-08-28

SODIUM CHLORIDE INHALATION SOLUTION, USP

Applicant Holopack International, LP

K number K972466

View details →

CAF 1997-08-19

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR

Applicant Brasamerica Medical Equipment, Inc.

K number K972371

View details →

CAF 1997-08-06

MDILOG, MODEL MDC-511

Applicant Medtrak Technologies, Inc.

K number K970344

View details →

CAF 1997-08-01

PORT-NEB

Applicant Medic-Aid , Ltd.

K number K971933

View details →

CAF 1997-07-31

HAND HELD MEDISPACER

Applicant Thayer Medical Corp.

K number K972237

View details →

CAF 1997-06-24

MASTER NEB II

Applicant Bremed Italia, S.R.L.

K number K970542

View details →

CAF 1997-04-16

OPTIVENT

Applicant Health Care Products, Inc.

K number K963793

View details →

CAF 1997-04-15

COMPRESSOR/NEBULIZER #3650

Applicant Devilbiss Health Care, Inc.

K number K970289

View details →

CAF 1997-04-01

JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009

Applicant Graham-Field, Inc.

K number K970035

View details →

CAF 1997-04-01

FPT NEBULIZER

Applicant Fluid Propulsion Technologies, Inc.

K number K970010

View details →

CAF 1997-03-19

THE SWIRLER NEBULIZER

Applicant Amici, Inc.

K number K952910

View details →

CAF 1997-02-28

THERA-MIST NEBULIZER MODEL-P3000

Applicant Pegasus Research Corp.

K number K962534

View details →

CAF 1997-02-25

HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT

Applicant Holden Walker Corp.

K number K963917

View details →

CAF 1997-02-25

RESPIFLO/S

Applicant Curtin & Associates International , Inc.

K number K962874

View details →

CAF 1997-02-25

RESPIFLO

Applicant Tyco Healthcare Deutschaland GmbH

K number K962872

View details →

CAF 1997-02-21

CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR

Applicant Contemporary Products, Inc.

K number K964994

View details →

CAF 1997-01-13

MISTY OX TURBOHEATER

Applicant Vital Signs, Inc.

K number K962438

View details →

CAF 1997-01-10

3050 SPORT-NEB

Applicant Medical Industries America, Inc.

K number K964078

View details →

CAF 1996-12-23

SIEMENS SERVO ULTRA NEBULIZER 345

Applicant Pacesetter, Inc.

K number K960854

View details →

CAF 1996-12-16

HEART NEBULIZER #100609

Applicant Vortran Medical Technology 1, Inc.

K number K963910

View details →

CAF 1996-12-10

LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70

Applicant Pari Holding Co.

K number K963924

View details →

CAF 1996-10-22

SALTERLABS 8660 SERIES NEBULIZER

Applicant Salter Labs

K number K962879

View details →

CAF 1996-10-17

OPTICHAMBER

Applicant Healthscan Products, Inc.

K number K962822

View details →

CAF 1996-08-26

SALTER LABS 8990 SERIES NEBULIZER

Applicant Salter Labs

K number K962085

View details →

CAF 1996-08-21

PRONEB TURBO COMPRESSOR MODEL 38V0200

Applicant Pari Holding Co.

K number K962072

View details →

CAF 1996-08-15

BAXTER NEBULIZER CAP MODEL 2D0868

Applicant Baxter Healthcare Corp

K number K962161

View details →

CAF 1996-08-15

DHD ACE WITH MASK KIT

Applicant Dhd Diemolding Healthcare Div.

K number K961973

View details →

CAF 1996-07-16

SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)

Applicant Salter Labs

K number K961476

View details →

CAF 1996-06-11

HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER

Applicant Automatic Liquid Packaging, Inc.

K number K955104

View details →

CAF 1996-05-17

WALKHALER PORTABLE COMPRESSOR MODEL 45F70

Applicant Pari Holding Co.

K number K960675

View details →

CAF 1996-04-26

MEDICATOR AEROSOL DRUG DELIVERY SYSTEM

Applicant Healthline Medical

K number K960397

View details →

CAF 1996-03-21

DUAL SPRAY MINISPACER

Applicant Thayer Medical Corp.

K number K955805

View details →

CAF 1996-02-27

PULMOMIST

Applicant Global Medical Ent., Inc.

K number K952326

View details →

CAF 1996-01-30

JET NEBULIZER

Applicant Devilbiss Health Care, Inc.

K number K952249

View details →

CAF 1995-12-28

A&D UN-231 ULTRASONIC HANDY NEBULIZER

Applicant A & D Corporate

K number K941627

View details →

CAF 1995-12-19

MEDOX CHAMPION COMPACT NEBULIZER

Applicant Medox Corp.

K number K954327

View details →

CAF 1995-11-03

THE SWIRLER AEROSOL SYSTEM

Applicant Amici, Inc.

K number K952893

View details →

CAF 1995-09-19

MARSAM MODEL 2000 NEBULIZER

Applicant Marsam Pharmaceuticals, Inc.

K number K933961

View details →

CAF 1995-09-12

MASTER-NEB NEBULIZER COMPRESSOR SYSTEM

Applicant Howard K. Mann & Assoc.

K number K943717

View details →

CAF 1995-08-28

DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)

Applicant Dhd Diemolding Healthcare Div.

K number K953206

View details →

CAF 1995-08-24

MEDI - PUMP

Applicant Thomas Industries

K number K950290

View details →

CAF 1995-08-24

DEVILBISS MODEL 5500

Applicant Devilbiss Health Care, Inc.

K number K946095

View details →

CAF 1995-06-20

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300

Applicant Impulso Trading Co.

K number K951259

View details →

CAF 1995-04-19

MEDI - PUMP

Applicant Thomas Industries

K number K950867

View details →

CAF 1995-03-21

3000 AEROSOL TWO

Applicant Medical Industries America, Inc.

K number K943990

View details →

CAF 1995-03-17

PARI-MASTER MODIFICATION

Applicant Pari Holding Co.

K number K935540

View details →

CAF 1995-03-16

AIRSEP NEWLIFE AIR OUTLET OPTION

Applicant Airsep Corp.

K number K944020

View details →

CAF 1995-03-10

3002 AEROMAX

Applicant Medical Industries America, Inc.

K number K942444

View details →

CAF 1995-02-24

4003 AEROLITE

Applicant Medical Industries America, Inc.

K number K942208

View details →

CAF 1995-01-27

FISONEB(R) II

Applicant Fisons Corp.

K number K950206

View details →