Cleared Traditional

K090848 - PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM

K090848 is an FDA 510(k) clearance for PREMIER STERILE SALINE WOUND WASH, manufactured by Premier Brands of America, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FQH cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K090848 · Premier Brands of America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
79d
Days
Class 2
Risk

K090848 is an FDA 510(k) clearance for the PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Premier Brands of America, Inc. (Mount Vernon, US). The FDA issued a Cleared decision on June 17, 2009 after a review of 79 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Premier Brands of America, Inc. devices

FDA 510(k) Submission Details - K090848

510(k) Number K090848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2009
Decision Date June 17, 2009
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
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 36
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K090848.
Bactisure Wound Lavage
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K110958 · Smith & Nephew, Inc. · Aug 2011
ERBE ERBEJET 2 SYSTEM
K072404 · Erbe USA, Inc. · Oct 2007
ERBE HELIX HYDRO-JET
K033590 · Erbe USA, Inc. · Jan 2004
HELIX HYDRO-JET
K022613 · Erbe USA, Inc. · Oct 2002