Cleared Traditional

K091719 - NEOSALUS LOTION

K091719 · Quinnova Pharmaceuticals · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
49d
Days
-
Risk

K091719 is an FDA 510(k) clearance for the NEOSALUS LOTION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Quinnova Pharmaceuticals (Newtown, US). The FDA issued a Cleared decision on July 30, 2009 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

FDA 510(k) Submission Details - K091719

510(k) Number K091719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date July 30, 2009
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 668
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K091719.
ELASTO-GEL MANUKA HONEY WOUND DRESSING
K083334 · Southwest Technologies, Inc. · Jul 2009
EXSALT SD7 WOUND DRESSING
K083870 · Exciton Technologies, Inc. · Jul 2009
SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
K091013 · Advanced Medical Solutions Limited · Jul 2009
ACTICOAT FLEX 7 DRESSING
K083113 · Smith & Nephew, Inc. · Jul 2009
CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES
K082910 · Aso, LLC · Jun 2009
OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
K090206 · Oculus Innovative Sciences, Inc. · Jun 2009
K091719 · NEOSALUS LOTION
Download PDF FDA Summary Quinnova Pharmaceutic…