Irrimax Corporation: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Irrimax Corporation” (first 2009, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 111 days. Since 2017 the median was 102 days, against 227 days for all cleared 510(k)s in the same product codes. 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 | 1 | 130 |
| 2021 | 1 | 93 |
| 2022 | 1 | 6 |
| 2023 | 0 | — |
| 2024 | 1 | 111 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Irrimax Corporation took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 227 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FQH | Lavage, Jet | 4 | 4 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
Review panels
Most recent Irrimax Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240552 | Irrisept Antimicrobial Wound Lavage | FRO | 2024-06-18 | 111 |
| K222804 | Irrisept Antimicrobial Wound Lavage | FQH | 2022-09-22 | 6 |
| K210536 | Irrisept Antimicrobial Wound Lavage | FQH | 2021-05-28 | 93 |
| K202222 | Irrisept Wound Debridement and Cleansing System | FQH | 2020-12-14 | 130 |
| K080779 | IRRISEPT WOUND CLEANSING SYSTEM | FQH | 2009-02-04 | 322 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-08-16.
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.
Device clinical trials
An industry sponsor named Irrimax Corporation is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05359666: Retrospective Independent Safety Review of Closed Irrisept Study (Completed, started 2020-03-31)
Frequently asked questions
How many FDA 510(k) clearances are listed under Irrimax Corporation?
FDA lists 5 510(k) clearances under the applicant name “Irrimax Corporation” (first 2009, latest 2024), across 2 product codes in 2 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 Irrimax Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Irrimax Corporation is 111 days. Since 2017: 102 days, versus 227 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Irrimax Corporation?
The most frequent FDA product codes under this applicant name are FQH (Lavage, Jet, 4); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 5 Irrimax Corporation clearances with predicates and recalls
- Run predicate analysis for product code FQH, Irrimax Corporation'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.