Cleared Traditional

K210987 - IRRIGO Wound Wash Jet System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210987 · Inopro, Inc. · General & Plastic Surgery device
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May 2022
Decision
425d
Days
Class 2
Risk

K210987 is an FDA 510(k) clearance for the IRRIGO Wound Wash Jet System. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Inopro, Inc. (Cowansville, CA). The FDA issued a Cleared decision on May 31, 2022 after a review of 425 days - an unusually long review period, suggesting complex equivalence evaluation.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Inopro, Inc. devices

Submission Details

510(k) Number K210987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2021
Decision Date May 31, 2022
Days to Decision 425 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 114d · This submission: 425d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K210987.
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