American Custom Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “American Custom Medical, Inc.” (first 1994, latest 1997), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 125 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 |
|---|---|---|---|
| NPK | Barrier, Synthetic, Intraoral | 3 | 3 |
| EMX | Balloon, Epistaxis | 1 | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
Review panels
Most recent American Custom Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965205 | TEFGEN - LS | NPK | 1997-04-30 | 125 |
| K964656 | TEFGEN GUIDED TISSUE MEMBRANE | NPK | 1997-02-10 | 82 |
| K944413 | ACM PTFE SURGICAL MESH | FTL | 1994-11-09 | 62 |
| K935137 | TEFGEN-FD | NPK | 1994-08-15 | 291 |
| K933800 | FLUOROFILM(R) | EMX | 1994-06-24 | 324 |
Recalls
openFDA lists no recalls under a recalling firm named American Custom Medical, Inc..
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 Custom Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “American Custom Medical, Inc.” (first 1994, latest 1997), across 3 product codes in 3 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 Custom Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Custom Medical, Inc. is 125 days.
Which FDA product codes appear under American Custom Medical, Inc.?
The most frequent FDA product codes under this applicant name are NPK (Barrier, Synthetic, Intraoral, 3); EMX (Balloon, Epistaxis, 1); FTL (Mesh, Surgical, Polymeric, 1).
Next steps
- See all 5 American Custom Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NPK, American Custom Medical, 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.