American Seal Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “American Seal Co.” (first 1989, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 85 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| FYF | Cap, Surgical | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
Most recent American Seal Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972227 | SHOE COVER | FYF | 1997-09-09 | 88 |
| K972187 | BOUFFANT CAP | KKX | 1997-09-09 | 91 |
| K970814 | NON-STERILE ISOLATION GOWN | FYC | 1997-05-27 | 82 |
| K964358 | AMSEAL SURGICAL FACE MASK | FXX | 1997-02-14 | 105 |
| K892557 | MAYTEX NON-STERILE LATEX EXAM GLOVE | LYY | 1989-05-31 | 51 |
| K892553 | MAYTEX PATIENT EXAMINATION GLOVES | LYY | 1989-05-25 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named American Seal Co..
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 Seal Co.?
FDA lists 6 510(k) clearances under the applicant name “American Seal Co.” (first 1989, latest 1997), across 5 product codes in 2 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 Seal Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Seal Co. is 85 days.
Which FDA product codes appear under American Seal Co.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 2); FXX (Mask, Surgical, 1); FYC (Gown, Isolation, Surgical, 1).
Next steps
- See all 6 American Seal Co. clearances with predicates and recalls
- Run predicate analysis for product code LYY, American Seal Co.'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.