American Convertors Div., American Pharmaseal: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “American Convertors Div., American Pharmaseal” (first 1980, latest 1984), across 14 product codes in 4 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 5 | 5 |
| FRG | Wrap, Sterilization | 2 | 2 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FPY | Sheet, Burn | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| FYB | Gown, Patient | 1 | 1 |
| FYF | Cap, Surgical | 1 | 1 |
Plus 4 more product codes.
Review panels
- General Hospital (11)
- General and Plastic Surgery (6)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
Most recent American Convertors Div., American Pharmaseal 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840957 | ANTIMICROBIAL INCISE DRAPE | KKX | 1984-06-07 | 93 |
| K832137 | CONVERTORS FLASH STERILIZING TRAY | FSM | 1983-08-12 | 42 |
| K830786 | DISIMETRIC RELEASE OF INSTRANETICS RAD | KOA | 1983-05-18 | 68 |
| K820994 | ABSORB FURN SHEET | FPY | 1982-05-13 | 35 |
| K813419 | COMFORT CUSHION DRY BURN PAD III | NAB | 1982-01-22 | 46 |
| K813296 | CONVERTORS STERILE DISP. LAP SPONGE II | EFQ | 1981-12-29 | 36 |
| K813078 | CONTURA DISPOS. SURG. FACE MASK | FXX | 1981-12-18 | 46 |
| K812554 | TOMAC STERILE DISP. LAP SPONGE | GDY | 1981-09-24 | 16 |
| K802919 | ISO-BAC INSTRUMENT WRAP | FRG | 1981-02-02 | 76 |
| K802998 | PATIENT CARE DISPOSABLE INFANT SHIRTS | KME | 1980-12-22 | 27 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Convertors Div., American Pharmaseal.
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 Pharmaseal Div. Ahsc (64 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Convertors Div., American Pharmaseal?
FDA lists 19 510(k) clearances under the applicant name “American Convertors Div., American Pharmaseal” (first 1980, latest 1984), 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 American Convertors Div., American Pharmaseal?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Convertors Div., American Pharmaseal is 36 days.
Which FDA product codes appear under American Convertors Div., American Pharmaseal?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 5); FRG (Wrap, Sterilization, 2); DXQ (Blood Pressure Cuff, 1).
Next steps
- See all 19 American Convertors Div., American Pharmaseal clearances with predicates and recalls
- Run predicate analysis for product code KKX, American Convertors Div., American Pharmaseal'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.