Atlas FDA

BWF

108 FDA 510(k) clearances · Product code

87 daysmedian time to decision
267 days90th percentile
108clearances measured

FDA profile

Official device name
Spirometer, Therapeutic (Incentive)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5690
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2010: 5 · 2011: 39 · 2012: 5 · 2013: 19 · 2015: 16 · 2019: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
InSee (K241152)Tidal Medical Technologies, LLC2025-08-21
AllPEP (K233855)Enchant Tek Co. , Ltd.2024-02-02
LungTrainer (MD2 & MD3) (K221058)Lung Trainers, LLC2023-07-05
Breathe+ (K222018)Peep Medical, LLC Dba Go2 Devices2023-06-02
Hudson RCI Triflo II Incentive Deep Breathing Exerciser (K220565)Medline Industries, Inc.2022-10-25
Pulsehaler (K203378)Respinova, Ltd.2021-03-31
D R Burton OxyPAP (K192000)D R Burton Healthcare, LLC2020-02-19
Acapella Choice Blue Vibratory PEP Device (K181660)Smiths Medical2019-10-24
Combined Aerobika OPEP and VersaPAP device (K183108)Trudell Medical International2019-08-16
Hudson RCI Voldyne Volumetric Exerciser (K182847)Teleflexmedical, Inc.2019-07-01
VersaPAP Positive Airway Pressure (PAP) Device (K173918)Trudell Medical International2018-08-17
VPOD ITPR (K172388)Advanced Circulatory System, A Wholly Owned Subsidiary OF2017-12-22
MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM (K160837)Medinet Srl2017-02-23
VibraPEP (K163091)Medica Holdings, LLC2017-02-21
iPEP System and vPEP (K160636)D R Burton Healthcare, LLC2016-08-03
O-PEP (K150044)Pari Respiratory Equipment, Inc.2016-05-27
VibraPEP (K153441)Medica Holdings, LLC2016-03-25
Aerobika OPEP Devive with Manometer (K150173)Trudell Medical International2015-10-15
AEROSURE MEDIC (K140772)Actegy , Ltd.2014-12-19
VOLUMETRIC INCENTIVE SPIROMETER (K141355)Besmed Health Business Corporation2014-09-03
TRIBALL INCENTIVE SPIROMETER (K133873)Besmed Health Business Corp2014-04-04
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE (K123400)Trudell Medical Intl.2013-05-16
LUNG FLUTE THERAPEUTIC (K091557)Medical Acoustics2010-01-04
PARI PEP S (K090829)Pari Respiratory Equipment, Inc.2009-07-21
RESPIFIT S, MODEL RS-LR1001004 (K080299)Eumedics Medizintechnik Und Marketing GmbH2009-01-13
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) (K070490)Advanced Circulatory Systems, Inc.2007-06-20
SPIRO-BALL (K053149)Leventon, S.A.2005-12-13
LIFESTYLE CIRCULATORY ENHANCER (K040084)Advanced Circulatory Systems, Inc.2004-04-07
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER (K033401)Advanced Circulatory Systems, Inc.2003-11-20
RESQPOD CIRCULATORY ENHANCER (K022906)Cprx, LLC2003-06-11
AEROPEP (K012368)Trudell Medical Intl.2002-02-12
ACAPELLA (K002768)Dhd Healthcare Corp.2000-12-05
CLINIFLO INCENTIVE SPIROMETER (K003146)Dhd Healthcare Corp.2000-11-21
TRI-BALL (K994074)Leventon, S.A.2000-06-08
INCENTIVE SPIROMETER (K000314)Engineered Medical Systems2000-04-12
FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01 (K992256)Intercontinental New Technologies, Inc.2000-01-11
ROADRUNNER, PEP THERAPY DEVICE (K991561)Dhd Healthcare Corp.1999-11-10
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE (K991300)Dhd Healthcare Corp.1999-07-12
RC CORNET, MODEL #44F50 (K983308)Pari Holding Co.1999-06-04
VITAL PEP (K984468)Vital Signs, Inc.1999-06-01
THERAPEP (K983467)Dhd Healthcare Corp.1999-04-02
MINI-CISER (K974848)Hougen Mfg., Inc.1998-08-06
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER (K972824)Pn Medical1998-04-03
PARI PEP THERAPY SYSTEM (K972042)Pari Holding Co.1997-08-05
DHD EMERALD PRODUCT (K970596)Dhd Diemolding Healthcare Div.1997-05-16
MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX (K954492)Mercury Medical1996-10-21
THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT (K962749)Diemolding Corp.1996-10-10
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE (K961077)Healthscan Products, Inc.1996-07-15
MISTASSIST BREATHING EXERCISER (K953055)The Merlin Corp.1996-02-08
THE BREATHER (K944412)Pal Medical, Inc.1995-04-26
LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER (K944344)Lung Technologies, Inc.1995-02-03
EXPIRATORY BREATHING EXERCISER (K945118)Dhd Diemolding Healthcare Div.1995-01-13
THERAPEP (K944900)Dhd Diemolding Healthcare Div.1995-01-06
MERCURY EXPIRATORY RESISTANCE EXERCISER (K942919)Mercury Ent., Inc. D/B/A Mercury Medical1994-09-19
THRESHOLD 2X INSPIRATORY MUSCLE TRAINER (K912943)Health Products, Inc.1992-01-30
TVS II ELECTRONIC INCENTIVE SPIROMETER (K910138)Monaghan Medical Corp.1991-03-12
THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 (K903489)Pegasus Research Corp.1990-12-10
RESPIREX 2 (K900754)Diemolding Corp.1990-03-15
AEROSOL INHALATION MONITOR (K893665)Vitalograph , Ltd.1989-08-21
AEROBICA - LUNG EXERCISER (K873540)MBA Healthcare Products, Inc.1988-02-04
AMBU RMT VALVE (K873579)Ambu, Inc.1987-12-30
TOTAL LUNG EXERCISER (TLE) (K871904)MBA Healthcare Products, Inc.1987-07-08
MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER (K871742)Health Products, Inc.1987-06-15
THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER (K870514)Health Products, Inc.1987-03-31
PFLEX EM(TM) (EXERCISE MONITOR) (K864719)Health Products, Inc.1987-03-16
THE LUNG GYM (XLATOR AND NLATOR) (K861564)El-Fax Company, Inc.1986-08-07
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER (K851334)American Pharmaseal Div. Ahsc1985-08-06
VITAPEP (K844963)Vitalograph , Ltd.1985-06-07
ELECATH INFANT ARTERIAL & VENOUS CANNU (K842369)Electro-Catheter Corp.1984-08-27
PFLEX RESPIRATORY MUSCLE EXERCISER (K842634)Health Scan, Inc.1984-08-10
VOFLEX (K840239)Dhd Medical Products Div. Diemolding Corp.1984-03-05
INSPIRATORY/EXPIRATORY MUSCLE EXERCIS (K840418)Inspiron Corp.1984-02-17
VOLUREX II (K833337)Dhd Medical Products Div. Diemolding Corp.1983-11-28
INSPIROMETER (K833012)Kinetix1983-11-08
GOAL TENDER (K832878)Dna Medical, Inc.1983-10-14
INSPIRATORY RESISTOR KIT (K831142)Dhd Medical Products Div. Diemolding Corp.1983-06-03
BE#6006 VAR. RESIS. INSPIR. MUSCLE (K821492)Instrumentation Industries, Inc.1982-09-24
SPI-RISE (K822359)Certified Respiratory Services, Inc.1982-08-27
RESPICORD (K821998)Novamed Products, Inc.1982-07-30
PFLEX TM (K820528)Health Scan, Inc.1982-03-26
MONAGHAN'S TRUE VOLUME EXERCISER (K820606)Monaghan Medical Corp.1982-03-23
OHIO VOLUME INCENTIVE SPIROMETER (K813476)Airco/Ohio Medical Products1981-12-31
K-MED ENCOURAGER INCENTIVE SPIROMETER (K810641)K-Med, Inc.1981-05-13
VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX (K801199)Chesebrough-Pond'S U.S.A. Co.1980-06-04
BUNN VOLUMAIRE RESPIRATORY EXERCISER (K800546)The John Bunn Co.1980-03-25
ARGYLE TRU-VOL (K800386)Sherwood Medical Co.1980-02-28
DISPOSABLE INCENTIVE SPIROMETER (K792598)Hospitak, Inc.1980-01-04
COUNTER UNIT (K792571)Empire Plastics Manufacturer1979-12-19
AIR INCENTIVE SPIROMETER, W/NEBULIZER (K792217)Airlife, Inc.1979-11-27
MODEL TM2-BEHIND-THE-EAR TINNITUS (K792214)Starkey Laboratories, Inc.1979-11-27
MOTIVATOR (K791842)Puritan Bennett Corp.1979-10-01
AIR INCENTIVE SPIROMETER (K791819)Airlife, Inc.1979-09-26
VOLUREX TM (K791015)Dhd Medical Products Div. Diemolding Corp.1979-06-13
LUNG FUNCTION AMPLIFIER EXERCISER (K790744)Empire Plastics Manufacturer1979-04-27
SPIROMETER, INCENTIVE CATALOG # 1750 (K781831)Hudson Oxygen Therapy Sales Co.1978-12-15
SPIROCARE 108-B (K782016)Marion Laboratories, Inc.1978-12-13
INCENT-O-NEB (K781731)B & F Medical Products, Inc.1978-12-05
CALCULATOR, WITH CHARGER (K781838)C.R. Bard, Inc.1978-11-21
EXERCISER, AIR-EZE INCENTIVE (K781833)Chesebrough-Pond'S U.S.A. Co.1978-11-14
RESPIRATORY EXERCISOR, VOLUME PULSE (K781669)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-10-23
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