American Pharmaseal Div. Ahsc: FDA filings under this applicant name
FDA lists 64 510(k) clearances under the applicant name “American Pharmaseal Div. Ahsc” (first 1980, latest 1987), across 38 product codes in 7 review panels. Median 510(k) review time under this name: 48 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 | 0 | — |
| 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 |
|---|---|---|---|
| KOD | Catheter, Urological | 6 | 6 |
| DQY | Catheter, Percutaneous | 5 | 5 |
| BSY | Catheters, Suction, Tracheobronchial | 4 | 4 |
| DRS | Transducer, Blood-Pressure, Extravascular | 3 | 3 |
| FSH | Tray, Surgical, Needle | 3 | 3 |
| FSM | Tray, Surgical, Instrument | 3 | 3 |
| BYY | Tube, Aspirating, Flexible, Connecting | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| FMG | Stopcock, I.V. Set | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
Plus 28 more product codes.
Review panels
- General Hospital (14)
- Cardiovascular (13)
- Anesthesiology (11)
- General and Plastic Surgery (11)
- Gastroenterology and Urology (10)
- Ophthalmic (1)
- Physical Medicine (1)
Most recent American Pharmaseal Div. Ahsc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874022 | PHARMASEAL WOUND IRRIGATION DEVICE | FQH | 1987-12-30 | 89 |
| K874517 | PHARMASEAL RUBBER URETHRAL CATHETER | KOD | 1987-12-03 | 31 |
| K874045 | PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER | NWU | 1987-12-03 | 59 |
| K873359 | AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE | CAI | 1987-11-06 | 77 |
| K872228 | PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM | FNM | 1987-09-04 | 87 |
| K872917 | JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER | BSY | 1987-08-11 | 15 |
| K871429 | ANTIMICROBIAL FOLEY CATHETER | KOD | 1987-08-10 | 123 |
| K871770 | AMERICAN PHARMASEAL WOUND DRESSING | FRO | 1987-06-26 | 51 |
| K870387 | EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE | BTR | 1987-05-08 | 98 |
| K870977 | PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE | KOD | 1987-04-01 | 22 |
54 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Pharmaseal Div. Ahsc.
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.
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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
- American Sterilizer Co. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Pharmaseal Div. Ahsc?
FDA lists 64 510(k) clearances under the applicant name “American Pharmaseal Div. Ahsc” (first 1980, latest 1987), across 38 product codes in 7 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 American Pharmaseal Div. Ahsc?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Pharmaseal Div. Ahsc is 48 days.
Which FDA product codes appear under American Pharmaseal Div. Ahsc?
The most frequent FDA product codes under this applicant name are KOD (Catheter, Urological, 6); DQY (Catheter, Percutaneous, 5); BSY (Catheters, Suction, Tracheobronchial, 4).
Next steps
- See all 64 American Pharmaseal Div. Ahsc clearances with predicates and recalls
- Run predicate analysis for product code KOD, American Pharmaseal Div. Ahsc'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.