Cleared Special

K222804 - Irrisept Antimicrobial Wound Lavage (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222804 · Irrimax Corporation · General & Plastic Surgery device
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Sep 2022
Decision
6d
Days
Class 2
Risk

K222804 is an FDA 510(k) clearance for the Irrisept Antimicrobial Wound Lavage. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Irrimax Corporation (Lawrenceville, US). The FDA issued a Cleared decision on September 22, 2022 after a review of 6 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5475 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Irrimax Corporation devices

Submission Details

510(k) Number K222804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2022
Decision Date September 22, 2022
Days to Decision 6 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 114d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FQH Lavage, Jet

All 52
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K222804.
BD Surgiphor™ Antimicrobial Irrigation System (910110)
K253996 · Becton, Dickinson and Company (BD) · Feb 2026
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
K253445 · Bd · Feb 2026
ERBEJET® 2 System
K231023 · Erbe Elektromedizin GmbH · Jun 2023
Armis VeriCyn Wound Wash
K220759 · Armis Biopharma, Inc. · May 2023
VERSAJET Hydrosurgery System (III)
K220964 · Smith & Nephew Medical Limited · May 2023
BD Surgiphor™ Antimicrobial Irrigation System
K221504 · Bd · Oct 2022