510(k) Report

FDA applicant

Irrimax Corporation

Lawrenceville, GA5 decisions2009–20242 recalls

FDA records 5 decisions for Irrimax Corporation (Lawrenceville, GA) from 2009 to 2024: 5 510(k) clearances. Most are in product codes FQH (Lavage, Jet) and FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Irrimax Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 12020: 12021: 12022: 12024: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2019

2017: 12019: 1
2009high 1 (2017) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Irrimax Corporation by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FQHLavage, Jet4decisions
  • FRODressing, Wound, Drug1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 111 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 136 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation · 20213cite it
  • K080779Irrisept Wound Cleansing SystemIrrimax Corporation · 20092cite it
  • K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 20201cites it

What has FDA decided for it lately?

  • K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2024
  • K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2022
  • K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021
  • K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020
  • K080779Irrisept Wound Cleansing SystemIrrimax Corporation · 20092 recalls

All 5 as Irrimax Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K080779Irrisept Wound Debridement and Cleansing System. 12 units per case.Aug 16, 2019Class II
  • K080779Irrisept OR, Finished Bottle Assembly 450 ml STEP 1Sep 5, 2017Class II