Perimed, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Perimed, Inc.” (first 1989, latest 1999), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 190 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 1 | 1 |
Review panels
Most recent Perimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990960 | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | LKD | 1999-09-23 | 185 |
| K974285 | PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT | DPW | 1998-05-28 | 195 |
| K935495 | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 | GEX | 1994-04-18 | 154 |
| K932068 | PERITEMP PF 4005 HEATER | DPW | 1993-12-07 | 222 |
| K922368 | PERIFLUX PF4001 LASER DOPPLER FLOWMETER | DPW | 1993-02-03 | 259 |
| K890828 | PERIFLUX PF3 | DPW | 1989-06-20 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Perimed, 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.
- Perimed AB (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Perimed, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Perimed, Inc.” (first 1989, latest 1999), 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 Perimed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Perimed, Inc. is 190 days.
Which FDA product codes appear under Perimed, Inc.?
The most frequent FDA product codes under this applicant name are DPW (Flowmeter, Blood, Cardiovascular, 4); GEX (Powered Laser Surgical Instrument, 1); LKD (Monitor, Carbon-Dioxide, Cutaneous, 1).
Next steps
- See all 6 Perimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPW, Perimed, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.