Cleared Traditional

PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM (K090848) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 K090848.
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