Allied Healthcare Products, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Allied Healthcare Products, Inc.” (first 1981, latest 2014), across 14 product codes in 4 review panels. Median 510(k) review time under this name: 138 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 315 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 9 | 9 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 4 | 4 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BYK | Tent, Oxygen, Electrically Powered | 1 | 1 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| CBL | Absorbent, Carbon-Dioxide | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent Allied Healthcare Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131098 | EMERGENCY PORTABLE VENTILATOR | BTL | 2014-04-09 | 356 |
| K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | BTL | 2014-04-02 | 274 |
| K090356 | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 | BTL | 2009-05-20 | 97 |
| K083507 | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS | BTL | 2009-05-18 | 173 |
| K083385 | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B | BTL | 2009-05-14 | 178 |
| K080063 | MASS CASUALTY VENTILATOR, MODEL MCV100 | BTL | 2008-08-15 | 218 |
| K072214 | PORTABLE VENTILATOR, MODEL EPV-100 | BTL | 2008-03-06 | 210 |
| K073171 | RESUSCITATION TIMER, MODEL L770-CPR | BTM | 2008-01-31 | 83 |
| K070636 | AUTOVENT 4000 WITH CPAP | BTL | 2007-07-13 | 128 |
| K070120 | AUTOVENT MODEL 4000 | BTL | 2007-05-03 | 111 |
16 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-08-12.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Allied Healthcare Products, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Allied Associates, Inc. (9 510(k)s)
- Allied Biomedical Corp. (9 510(k)s)
- Allied Instrumentation Laboratory (7 510(k)s)
- Allied Rubber Industries Sdn. Bhd. (2 510(k)s)
- Allied Signal, Inc. (2 510(k)s)
- Allied Advanced Technologies (Aat) (1 510(k)s)
- Allied Dental Solutions (1 510(k)s)
- Allied Fisher Scientific (1 510(k)s)
- Allied Hill Enterprises, Ltd. (1 510(k)s)
- Allied Medical Technologies, Inc. (1 510(k)s)
- Allied Photo Products Co., Inc. (1 510(k)s)
- Allied Systems Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Allied Healthcare Products, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Allied Healthcare Products, Inc.” (first 1981, latest 2014), across 14 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Allied Healthcare Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Allied Healthcare Products, Inc. is 138 days.
Which FDA product codes appear under Allied Healthcare Products, Inc.?
The most frequent FDA product codes under this applicant name are BTL (Ventilator, Emergency, Powered (Resuscitator), 9); BTM (Ventilator, Emergency, Manual (Resuscitator), 4); CBK (Ventilator, Continuous, Facility Use, 2).
Next steps
- See all 26 Allied Healthcare Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTL, Allied Healthcare Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.