Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Irrimax Corporation · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
322 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240552 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2024-06-18 | 111 | 0 |
| K222804 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2022-09-22 | 6 | 0 |
| K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021-05-28 | 93 | 0 |
| K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020-12-14 | 130 | 0 |
| K080779 | IRRISEPT WOUND CLEANSING SYSTEM | Irrimax Corporation | 2009-02-04 | 322 | 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