FQH · Class II · 21 CFR 880.5475

FDA Product Code FQH: Lavage, Jet

Leading manufacturers include Erbe USA, Inc., Irrimax Corporation and Bd.

53
Total
53
Cleared
144d
Avg days
1979
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 108d recently vs 145d historically

FDA 510(k) Cleared Lavage, Jet Devices (Product Code FQH)

53 devices
1–24 of 53
Cleared Feb 25, 2026
BD Surgiphor™ Antimicrobial Irrigation System (910110)
K253996
Becton, Dickinson and Company (BD)
General & Plastic Surgery · 75d
Cleared Feb 20, 2026
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
K253445
Bd
General & Plastic Surgery · 141d
Cleared Jun 15, 2023
ERBEJET® 2 System
K231023
Erbe Elektromedizin GmbH
General & Plastic Surgery · 65d
Cleared May 25, 2023
Armis VeriCyn Wound Wash
K220759
Armis Biopharma, Inc.
General & Plastic Surgery · 436d
Cleared May 16, 2023
VERSAJET Hydrosurgery System (III)
K220964
Smith & Nephew Medical Limited
General & Plastic Surgery · 410d
Cleared Oct 14, 2022
BD Surgiphor™ Antimicrobial Irrigation System
K221504
Bd
General & Plastic Surgery · 144d
Cleared Sep 22, 2022
Irrisept Antimicrobial Wound Lavage
K222804
Irrimax Corporation
General & Plastic Surgery · 6d
Cleared May 31, 2022
IRRIGO Wound Wash Jet System
K210987
Inopro, Inc.
General & Plastic Surgery · 425d
Cleared Mar 23, 2022
BD Surgiphor Antimicrobial Irrigation System
K213616
Becton, Dickinson and Company
General & Plastic Surgery · 128d
Cleared May 28, 2021
Irrisept Antimicrobial Wound Lavage
K210536
Irrimax Corporation
General & Plastic Surgery · 93d
Cleared Dec 14, 2020
Irrisept Wound Debridement and Cleansing System
K202222
Irrimax Corporation
General & Plastic Surgery · 130d
Cleared Oct 23, 2020
SURGIPHOR Wound Irrigation System
K202071
Orthophor, LLC
General & Plastic Surgery · 88d
Cleared Jan 23, 2020
Bactisure Wound Lavage
K192349
Next Science, LLC
General & Plastic Surgery · 147d
Cleared Sep 07, 2016
Next Science Irrigation Solution
K161165
Next Science, LLC
General & Plastic Surgery · 135d
Cleared Jul 15, 2015
The VersaJet II Hydrosurgery System
K143115
Smith & Nephew, Inc.
General Hospital · 258d
Cleared Aug 21, 2012
HY-CHLO(TM)WOUND SCRUB
K113312
Patrin Pharma
General Hospital · 286d
Cleared Dec 14, 2011
EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
K111313
Alcavis Hdc, LLC
General Hospital · 218d
Cleared Aug 01, 2011
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
K110958
Smith & Nephew, Inc.
General Hospital · 118d
Cleared Oct 31, 2007
ERBE ERBEJET 2 SYSTEM
K072404
Erbe USA, Inc.
General Hospital · 65d
Cleared Jan 30, 2004
ERBE HELIX HYDRO-JET
K033590
Erbe USA, Inc.
General Hospital · 81d
Cleared Oct 25, 2002
HELIX HYDRO-JET
K022613
Erbe USA, Inc.
General Hospital · 80d
Cleared Mar 31, 2000
HYDROCISION DEBDRIDEMENT SYSTEM
K991383
Hydrocision, Inc.
General Hospital · 345d
Cleared Nov 13, 1998
BLOWER/MISTER
K983135
Cardiothoracic Systems, Inc.
General Hospital · 66d
Cleared Jan 06, 1998
CHASE ANASTOMOSIS VISUALIZATION DEVICE
K974568
Chase Medical, Inc.
General Hospital · 32d

About Product Code FQH - Regulatory Context

510(k) Submission Activity

53 total 510(k) submissions under product code FQH since 1979, with 53 receiving FDA clearance (average review time: 144 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - FQH Product Code

Recent submissions under FQH have taken an average of 108 days to reach a decision - down from 145 days historically, suggesting improved FDA processing for this classification.

FQH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →