Cleared Traditional

K213616 - BD Surgiphor Antimicrobial Irrigation System

K213616 is an FDA 510(k) clearance for BD Surgiphor Antimicrobial Irrigation S..., manufactured by Becton, Dickinson and Company. The device is a Class 2 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K213616

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.

FQH Device Classification - Class 2, Special Controls

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 39
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