Panels › Anesthesiology › Product code BWF · Class 2
Spirometer, Therapeutic (Incentive)
Regulation 868.5690
0510(k)s in 12 months (108 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in BWF
| Company | 510(k)s | Recalls |
|---|---|---|
| Dhd Healthcare Corp. | 5 | 0 |
| Dhd Medical Products Div. Diemolding Corp. | 4 | 0 |
| Health Products, Inc. | 4 | 0 |
| Advanced Circulatory Systems, Inc. | 3 | 0 |
| Chesebrough-Pond'S U.S.A. Co. | 3 | 0 |
| Dhd Diemolding Healthcare Div. | 3 | 0 |
| Trudell Medical International | 3 | 0 |
| Airlife, Inc. | 2 | 0 |
| Besmed Health Business Corp | 2 | 0 |
| D R Burton Healthcare, LLC | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2025 | K241152 | InSee Tidal Medical Technologies, LLC | BWF |
| Feb 2, 2024 | K233855 | AllPEP Enchant Tek Co. , Ltd., TW | BWF |
| Jul 5, 2023 | K221058 | LungTrainer (MD2 & MD3) Lung Trainers, LLC | BWF |
| Jun 2, 2023 | K222018 | Breathe+ Peep Medical, LLC Dba Go2 Devices | BWF |
| Oct 25, 2022 | K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser Medline Industries, Inc. | BWF |
| Mar 31, 2021 | K203378 | Pulsehaler Respinova, Ltd., IL | BWF |
| Feb 19, 2020 | K192000 | D R Burton OxyPAP D R Burton Healthcare, LLC | BWF |
| Oct 24, 2019 | K181660 | Acapella Choice Blue Vibratory PEP Device Smiths Medical | BWF |
| Aug 16, 2019 | K183108 | Combined Aerobika OPEP and VersaPAP device Trudell Medical International, CA | BWF |
| Jul 1, 2019 | K182847 | Hudson RCI Voldyne Volumetric Exerciser Teleflexmedical, Inc. | BWF |
| Aug 17, 2018 | K173918 | VersaPAP Positive Airway Pressure (PAP) Device Trudell Medical International, CA | BWF |
| Dec 22, 2017 | K172388 | VPOD ITPR Advanced Circulatory System, A Wholly Owned Subsidiary OF | BWF |
| Feb 23, 2017 | K160837 | MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM Medinet Srl, IT | BWF |
| Feb 21, 2017 | K163091 | VibraPEP Medica Holdings, LLC | BWF |
| Aug 3, 2016 | K160636 | iPEP System and vPEP D R Burton Healthcare, LLC | BWF |
| May 27, 2016 | K150044 | O-PEP Pari Respiratory Equipment, Inc. | BWF |
| Mar 25, 2016 | K153441 | VibraPEP Medica Holdings, LLC | BWF |
| Oct 15, 2015 | K150173 | Aerobika OPEP Devive with Manometer Trudell Medical International, CA | BWF |
| Dec 19, 2014 | K140772 | AEROSURE MEDIC Actegy , Ltd. | BWF |
| Sep 3, 2014 | K141355 | VOLUMETRIC INCENTIVE SPIROMETER Besmed Health Business Corporation, TW | BWF |
| Apr 4, 2014 | K133873 | TRIBALL INCENTIVE SPIROMETER Besmed Health Business Corp, TW | BWF |
| May 16, 2013 | K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE Trudell Medical Intl., CA | BWF |
| Jan 4, 2010 | K091557 | LUNG FLUTE THERAPEUTIC Medical Acoustics | BWF |
| Jul 21, 2009 | K090829 | PARI PEP S Pari Respiratory Equipment, Inc. | BWF |
| Jan 13, 2009 | K080299 | RESPIFIT S, MODEL RS-LR1001004 Eumedics Medizintechnik Und Marketing GmbH | BWF |
| Jun 20, 2007 | K070490 | CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) Advanced Circulatory Systems, Inc. | BWF |
| Dec 13, 2005 | K053149 | SPIRO-BALL Leventon, S.A., ES | BWF |
| Apr 7, 2004 | K040084 | LIFESTYLE CIRCULATORY ENHANCER Advanced Circulatory Systems, Inc. | BWF |
| Nov 20, 2003 | K033401 | MODIFICATION TO RESQPOD CIRCULATORY ENHANCER Advanced Circulatory Systems, Inc. | BWF |
| Jun 11, 2003 | K022906 | RESQPOD CIRCULATORY ENHANCER Cprx, LLC | BWF |
| Feb 12, 2002 | K012368 | AEROPEP Trudell Medical Intl., CA | BWF |
| Dec 5, 2000 | K002768 | ACAPELLA Dhd Healthcare Corp. | BWF |
| Nov 21, 2000 | K003146 | CLINIFLO INCENTIVE SPIROMETER Dhd Healthcare Corp. | BWF |
| Jun 8, 2000 | K994074 | TRI-BALL Leventon, S.A., ES | BWF |
| Apr 12, 2000 | K000314 | INCENTIVE SPIROMETER Engineered Medical Systems | BWF |
| Jan 11, 2000 | K992256 | FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01 Intercontinental New Technologies, Inc. | BWF |
| Nov 10, 1999 | K991561 | ROADRUNNER, PEP THERAPY DEVICE Dhd Healthcare Corp. | BWF |
| Jul 12, 1999 | K991300 | BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE Dhd Healthcare Corp. | BWF |
| Jun 4, 1999 | K983308 | RC CORNET, MODEL #44F50 Pari Holding Co. | BWF |
| Jun 1, 1999 | K984468 | VITAL PEP Vital Signs, Inc. | BWF |
| Apr 2, 1999 | K983467 | THERAPEP Dhd Healthcare Corp. | BWF |
| Aug 6, 1998 | K974848 | MINI-CISER Hougen Mfg., Inc. | BWF |
| Apr 3, 1998 | K972824 | THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER Pn Medical | BWF |
| Aug 5, 1997 | K972042 | PARI PEP THERAPY SYSTEM Pari Holding Co. | BWF |
| May 16, 1997 | K970596 | DHD EMERALD PRODUCT Dhd Diemolding Healthcare Div. | BWF |
| Oct 21, 1996 | K954492 | MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX Mercury Medical | BWF |
| Oct 10, 1996 | K962749 | THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT Diemolding Corp. | BWF |
| Jul 15, 1996 | K961077 | PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE Healthscan Products, Inc. | BWF |
| Feb 8, 1996 | K953055 | MISTASSIST BREATHING EXERCISER The Merlin Corp. | BWF |
| Apr 26, 1995 | K944412 | THE BREATHER Pal Medical, Inc. | BWF |
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