Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BYI — Predicate Candidate Screening
58 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
254 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | 2026-04-30 | 234 | 0 |
| K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | 2025-10-02 | 195 | 0 |
| K242063 | LibAirty Airway Clearance System | Synchrony Medical , Ltd. | 2024-12-19 | 157 | 0 |
| K240959 | Respiratory Muscle Trainer | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-18 | 254 | 0 |
| K233441 | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation | 2024-03-22 | 156 | 0 |
| K222496 | Electromed SmartVest Airway Clearance System | Electromed, Inc. | 2022-11-18 | 92 | 0 |
| K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | 2021-02-12 | 253 | 0 |
| K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. | 2021-01-15 | 77 | 0 |
| K173603 | Monarch Airway Clearance System | Hill-Rom Holdings, Inc. | 2018-10-24 | 337 | 0 |
| K163378 | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | 2017-03-17 | 106 | 0 |
| K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | 2015-05-07 | 245 | 0 |
| K132794 | SMARTVEST AIRWAY CLEARANCE SYSTEM | Electromed, Inc. | 2013-12-19 | 104 | 0 |
| K121587 | BREATH SHAKE | Cheen Houng Ent. Co. , Ltd. | 2013-11-22 | 540 | 0 |
| K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | International Biophysics Corporation | 2013-03-27 | 225 | 0 |
| K121170 | RESIN 11 | Respinnovation Sas | 2012-07-13 | 87 | 0 |
| K103176 | FREQUENCER | Dymedso, Inc. | 2011-01-26 | 90 | 0 |
| K100749 | FREQUENCER MODEL V2X | Dymedso, Inc. | 2010-08-31 | 168 | 0 |
| K063645 | FREQUENCER, MODEL 1001 | Dymedso, Inc. | 2007-03-15 | 98 | 0 |
| K060439 | LUNG FLUTE | Medical Acoustics, LLC | 2006-06-22 | 121 | 0 |
| K053248 | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL | Electromed, Inc. | 2005-12-01 | 10 | 0 |
| K051383 | THE INCOURAGE SYSTEM | Respiratory Technologies, Incorporated | 2005-06-17 | 21 | 0 |
| K040367 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ | Electromed, Inc. | 2004-04-07 | 54 | 0 |
| K031876 | ELECTRO FLO PERCUSSOR, MODEL 5000 | Med Systems | 2003-11-21 | 157 | 0 |
| K024309 | THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 | Advanced Respiratory | 2003-02-21 | 59 | 0 |
| K012928 | ABI VEST AIRWAY CLEARANCE SYSTEM | Advanced Respiratory | 2001-10-09 | 39 | 0 |
| K993629 | ABI VEST AIRWAY CLEARANCE SYSTEM | American Biosystems, Inc. | 2000-01-21 | 86 | 0 |
| K982889 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 | Electromed, Inc. | 1999-06-01 | 288 | 0 |
| K974849 | X-AIR-CISER | Hougen Mfg., Inc. | 1998-08-06 | 220 | 0 |
| K972859 | FLUTTER D | Bradstreet Clinical Research Assoc., Inc. | 1998-06-05 | 305 | 0 |
| K965192 | THAIRAPY VEST SYSTEM | American Biosystems, Inc. | 1997-06-24 | 182 | 0 |
| K946083 | FLUTTER(R) | Bradstreet Clinical Research Assoc., Inc. | 1995-03-13 | 90 | 1 |
| K931988 | 3P (PULMONARY PERCUSSIVE PACK) | Delta Medical Manuf, Inc. | 1994-10-28 | 554 | 0 |
| K936121 | THAIRAPY SYSTEM | American Biosystems, Inc. | 1994-08-02 | 222 | 0 |
| K940986 | FLUTTER(R) | Varioraw SA | 1994-05-24 | 84 | 0 |
| K913014 | EMS PERCUSSOR | Engineered Medical Systems | 1991-10-23 | 107 | 0 |
| K901026 | MJ PERCUSSOR(TM) | Merced Medical, Inc. | 1990-03-15 | 9 | 0 |
| K892862 | FLEX-CUP PERCUSSOR | Life Design Systems, Inc. | 1989-05-25 | 37 | 0 |
| K882604 | PULMO-PATTY | Tower Stopper, Inc. | 1989-01-04 | 194 | 0 |
| K884098 | THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101 | American Biosystems, Inc. | 1988-12-16 | 79 | 0 |
| K883899 | MANUAL PERCUSSOR CUPS | Medical Components, Inc. | 1988-12-13 | 89 | 0 |
| K880597 | THUMPER MODEL P-1000 | Micro Tek Engineering | 1988-03-29 | 47 | 0 |
| K863658 | SALTER LABS 3000 SERIES PERCUSSORS | Salter Labs | 1986-10-06 | 18 | 0 |
| K860510 | NEONATE PERCUSSOR | Ballard Medical Products | 1986-02-20 | 9 | 0 |
| K855129 | NEOCUSSOR (MASSAGER, BATTERY) POWERED | General Physiotherapy, Inc. | 1986-01-23 | 31 | 0 |
| K853965 | NEOGUARD CHEST PERCUSSOR | Cas Medical Systems, Inc. | 1985-12-03 | 68 | 0 |
| K842608 | INFANT PERCUSSOR PA-010 | Alpha Medical Systems | 1984-07-23 | 18 | 0 |
| K821265 | PNEUMOPULSSOR (PPS II) | Strom Corp. | 1982-07-26 | 84 | 0 |
| K821570 | PNEUMO PULSSOR III | Strom Corp. | 1982-06-03 | 7 | 0 |
| K813438 | PNEUMO PULSSOR | Strom Corp. | 1981-12-29 | 21 | 0 |
| K812803 | INFANT PERCUSSOR #5534 | Hudson Oxygen Therapy Sales Co. | 1981-12-03 | 58 | 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