Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Allied Healthcare Products, Inc. · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
295 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131098 | EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | 2014-04-09 | 356 | 0 |
| K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | 2014-04-02 | 274 | 0 |
| K090356 | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 | Allied Healthcare Products, Inc. | 2009-05-20 | 97 | 0 |
| K083507 | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS | Allied Healthcare Products, Inc. | 2009-05-18 | 173 | 0 |
| K083385 | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B | Allied Healthcare Products, Inc. | 2009-05-14 | 178 | 0 |
| K080063 | MASS CASUALTY VENTILATOR, MODEL MCV100 | Allied Healthcare Products, Inc. | 2008-08-15 | 218 | 0 |
| K072214 | PORTABLE VENTILATOR, MODEL EPV-100 | Allied Healthcare Products, Inc. | 2008-03-06 | 210 | 0 |
| K073171 | RESUSCITATION TIMER, MODEL L770-CPR | Allied Healthcare Products, Inc. | 2008-01-31 | 83 | 0 |
| K070636 | AUTOVENT 4000 WITH CPAP | Allied Healthcare Products, Inc. | 2007-07-13 | 128 | 0 |
| K070120 | AUTOVENT MODEL 4000 | Allied Healthcare Products, Inc. | 2007-05-03 | 111 | 0 |
| K062080 | RESUSCITATION TIMER, MODEL L770-CPR | Allied Healthcare Products, Inc. | 2006-10-18 | 89 | 0 |
| K051260 | SCHUCO MIST AND SCHUCO DELUXE MIST | Allied Healthcare Products, Inc. | 2005-09-15 | 123 | 0 |
| K014071 | PMX DISPOSABLE BAG MASK RESUSCITATOR | Allied Healthcare Products, Inc. | 2002-10-01 | 295 | 0 |
| K973106 | GOLEMB DISPOSABLE BAG MASK RESUSCITATOR | Allied Healthcare Products, Inc. | 1998-01-29 | 163 | 0 |
| K972203 | BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL | Allied Healthcare Products, Inc. | 1997-11-06 | 148 | 0 |
| K955865 | BEAR CUB INFANT PRESSURE VENTILATOR | Allied Healthcare Products, Inc. | 1996-08-06 | 222 | 0 |
| K941547 | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT | Allied Healthcare Products, Inc. | 1995-03-01 | 336 | 0 |
| K932936 | L.A.P. II SPRIOMETRY SYSTEM | Allied Healthcare Products, Inc. | 1994-02-10 | 239 | 0 |
| K924100 | OXYGEN CONCENTRATOR | Allied Healthcare Products, Inc. | 1993-03-19 | 218 | 0 |
| K822614 | BLOOD PRESSURE MONITORING DEVICES | Allied Healthcare Products, Inc. | 1982-09-21 | 22 | 0 |
| K811260 | BARALYME CO2 ABSORBENT | Allied Healthcare Products, Inc. | 1981-05-27 | 21 | 0 |
| K810938 | MASS SPECTROMETER-MEDSPECT II | Allied Healthcare Products, Inc. | 1981-04-23 | 16 | 0 |
| K810939 | NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI. | Allied Healthcare Products, Inc. | 1981-04-23 | 16 | 0 |
| K810927 | RESPIRATORY INTENSIVE CARE SYSTEM (RICS) | Allied Healthcare Products, Inc. | 1981-04-14 | 8 | 0 |
| K810585 | SARA | Allied Healthcare Products, Inc. | 1981-03-24 | 20 | 0 |
| K810490 | GOMCO SUCTION PUMP CABINET CHANGE | Allied Healthcare Products, Inc. | 1981-03-13 | 17 | 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