Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perimed AB — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152930 | PeriFlux6000 | Perimed AB | 2016-05-05 | 213 | 0 |
| K131253 | PERIFLUX 6000 | Perimed AB | 2013-10-22 | 173 | 0 |
| K120884 | PERICAM PSI | Perimed AB | 2012-07-03 | 102 | 0 |
| K011899 | PF 5050 PRESSURE UNIT, MODEL PF 5050 | Perimed AB | 2001-11-06 | 141 | 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