Perimeter Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Perimeter Medical, Inc.” (first 1985, latest 1985), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Perimeter Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844925 | PERIMETER MEDIASTINAL DRAIN | — | 1985-03-18 | 89 |
| K844924 | PERIMETER YANKAUER SUCTION TIPS & SETS | — | 1985-03-18 | 89 |
| K844923 | PERIMETER SUMP DRAIN | — | 1985-03-18 | 89 |
| K844922 | PERIMETER THORACIC CATHETER | GBX | 1985-03-18 | 89 |
| K844921 | PERIMETER CLOSED WOUND RESEVOIR | GCY | 1985-03-18 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Perimeter 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.
- Perimeter Medical Imaging, Inc. (3 510(k)s)
- Perimeter Medical Imaging Ai, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Perimeter Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Perimeter Medical, Inc.” (first 1985, latest 1985), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Perimeter Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Perimeter Medical, Inc. is 89 days.
Which FDA product codes appear under Perimeter Medical, Inc.?
The most frequent FDA product codes under this applicant name are GBX (Catheter, Irrigation, 1); GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered, 1).
Next steps
- See all 5 Perimeter Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GBX, Perimeter 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.