Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BWF — Predicate Candidate Screening
108 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
267 days90th percentile
108clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241152 | InSee | Tidal Medical Technologies, LLC | 2025-08-21 | 482 | 0 |
| K233855 | AllPEP | Enchant Tek Co. , Ltd. | 2024-02-02 | 59 | 0 |
| K221058 | LungTrainer (MD2 & MD3) | Lung Trainers, LLC | 2023-07-05 | 450 | 0 |
| K222018 | Breathe+ | Peep Medical, LLC Dba Go2 Devices | 2023-06-02 | 329 | 0 |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Medline Industries, Inc. | 2022-10-25 | 239 | 0 |
| K203378 | Pulsehaler | Respinova, Ltd. | 2021-03-31 | 134 | 0 |
| K192000 | D R Burton OxyPAP | D R Burton Healthcare, LLC | 2020-02-19 | 208 | 0 |
| K181660 | Acapella Choice Blue Vibratory PEP Device | Smiths Medical | 2019-10-24 | 486 | 0 |
| K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | 2019-08-16 | 281 | 0 |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. | 2019-07-01 | 265 | 0 |
| K173918 | VersaPAP Positive Airway Pressure (PAP) Device | Trudell Medical International | 2018-08-17 | 238 | 0 |
| K172388 | VPOD ITPR | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017-12-22 | 136 | 0 |
| K160837 | MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM | Medinet Srl | 2017-02-23 | 335 | 0 |
| K163091 | VibraPEP | Medica Holdings, LLC | 2017-02-21 | 109 | 0 |
| K160636 | iPEP System and vPEP | D R Burton Healthcare, LLC | 2016-08-03 | 149 | 0 |
| K150044 | O-PEP | Pari Respiratory Equipment, Inc. | 2016-05-27 | 501 | 0 |
| K153441 | VibraPEP | Medica Holdings, LLC | 2016-03-25 | 119 | 0 |
| K150173 | Aerobika OPEP Devive with Manometer | Trudell Medical International | 2015-10-15 | 262 | 0 |
| K140772 | AEROSURE MEDIC | Actegy , Ltd. | 2014-12-19 | 267 | 0 |
| K141355 | VOLUMETRIC INCENTIVE SPIROMETER | Besmed Health Business Corporation | 2014-09-03 | 103 | 0 |
| K133873 | TRIBALL INCENTIVE SPIROMETER | Besmed Health Business Corp | 2014-04-04 | 105 | 0 |
| K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE | Trudell Medical Intl. | 2013-05-16 | 192 | 0 |
| K091557 | LUNG FLUTE THERAPEUTIC | Medical Acoustics | 2010-01-04 | 222 | 0 |
| K090829 | PARI PEP S | Pari Respiratory Equipment, Inc. | 2009-07-21 | 117 | 0 |
| K080299 | RESPIFIT S, MODEL RS-LR1001004 | Eumedics Medizintechnik Und Marketing GmbH | 2009-01-13 | 343 | 0 |
| K070490 | CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) | Advanced Circulatory Systems, Inc. | 2007-06-20 | 120 | 0 |
| K053149 | SPIRO-BALL | Leventon, S.A. | 2005-12-13 | 33 | 0 |
| K040084 | LIFESTYLE CIRCULATORY ENHANCER | Advanced Circulatory Systems, Inc. | 2004-04-07 | 83 | 0 |
| K033401 | MODIFICATION TO RESQPOD CIRCULATORY ENHANCER | Advanced Circulatory Systems, Inc. | 2003-11-20 | 27 | 0 |
| K022906 | RESQPOD CIRCULATORY ENHANCER | Cprx, LLC | 2003-06-11 | 281 | 0 |
| K012368 | AEROPEP | Trudell Medical Intl. | 2002-02-12 | 201 | 0 |
| K002768 | ACAPELLA | Dhd Healthcare Corp. | 2000-12-05 | 90 | 0 |
| K003146 | CLINIFLO INCENTIVE SPIROMETER | Dhd Healthcare Corp. | 2000-11-21 | 42 | 0 |
| K994074 | TRI-BALL | Leventon, S.A. | 2000-06-08 | 189 | 0 |
| K000314 | INCENTIVE SPIROMETER | Engineered Medical Systems | 2000-04-12 | 71 | 0 |
| K992256 | FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01 | Intercontinental New Technologies, Inc. | 2000-01-11 | 189 | 0 |
| K991561 | ROADRUNNER, PEP THERAPY DEVICE | Dhd Healthcare Corp. | 1999-11-10 | 190 | 0 |
| K991300 | BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE | Dhd Healthcare Corp. | 1999-07-12 | 87 | 0 |
| K983308 | RC CORNET, MODEL #44F50 | Pari Holding Co. | 1999-06-04 | 256 | 0 |
| K984468 | VITAL PEP | Vital Signs, Inc. | 1999-06-01 | 167 | 0 |
| K983467 | THERAPEP | Dhd Healthcare Corp. | 1999-04-02 | 189 | 0 |
| K974848 | MINI-CISER | Hougen Mfg., Inc. | 1998-08-06 | 220 | 0 |
| K972824 | THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER | Pn Medical | 1998-04-03 | 247 | 0 |
| K972042 | PARI PEP THERAPY SYSTEM | Pari Holding Co. | 1997-08-05 | 64 | 0 |
| K970596 | DHD EMERALD PRODUCT | Dhd Diemolding Healthcare Div. | 1997-05-16 | 87 | 0 |
| K954492 | MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX | Mercury Medical | 1996-10-21 | 390 | 0 |
| K962749 | THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LAR | Diemolding Corp. | 1996-10-10 | 87 | 0 |
| K961077 | PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE | Healthscan Products, Inc. | 1996-07-15 | 119 | 0 |
| K953055 | MISTASSIST BREATHING EXERCISER | The Merlin Corp. | 1996-02-08 | 223 | 0 |
| K944412 | THE BREATHER | Pal Medical, Inc. | 1995-04-26 | 230 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda