Cleared Traditional

K213616 - BD Surgiphor Antimicrobial Irrigation S...

K213616 is the FDA 510(k) clearance for BD Surgiphor Antimicrobial Irrigation S... by Becton, Dickinson and Company. It is a Class 2 General & Plastic Surgery device (product code FQH) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K213616 · Becton, Dickinson and Company · General & Plastic Surgery device
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Mar 2022
Decision
128d
Days
Class 2
Risk

K213616 is an FDA 510(k) clearance for the BD Surgiphor Antimicrobial Irrigation System. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Vernon Hills, US). The FDA issued a Cleared decision on March 23, 2022 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton, Dickinson and Company devices

Submission Details

510(k) Number K213616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2021
Decision Date March 23, 2022
Days to Decision 128 days
Submission Type Traditional
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
13d slower than avg
Panel avg: 115d · This submission: 128d
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 31
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K213616.
BD Surgiphor™ Antimicrobial Irrigation System
K221504 · Bd · Oct 2022
Irrisept Antimicrobial Wound Lavage
K222804 · Irrimax Corporation · Sep 2022
IRRIGO Wound Wash Jet System
K210987 · Inopro, Inc. · May 2022
Irrisept Antimicrobial Wound Lavage
K210536 · Irrimax Corporation · May 2021
Irrisept Wound Debridement and Cleansing System
K202222 · Irrimax Corporation · Dec 2020
SURGIPHOR Wound Irrigation System
K202071 · Orthophor, LLC · Oct 2020