Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perimed, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
259 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990960 | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | Perimed, Inc. | 1999-09-23 | 185 | 0 |
| K974285 | PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT | Perimed, Inc. | 1998-05-28 | 195 | 0 |
| K935495 | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 | Perimed, Inc. | 1994-04-18 | 154 | 0 |
| K932068 | PERITEMP PF 4005 HEATER | Perimed, Inc. | 1993-12-07 | 222 | 0 |
| K922368 | PERIFLUX PF4001 LASER DOPPLER FLOWMETER | Perimed, Inc. | 1993-02-03 | 259 | 0 |
| K890828 | PERIFLUX PF3 | Perimed, Inc. | 1989-06-20 | 119 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda