Cleared Traditional

K083042 - WOUND FLUSH, STERILE WATER & NORMAL SALINE

K083042 · Nurse Assist, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
65d
Days
-
Risk

K083042 is an FDA 510(k) clearance for the WOUND FLUSH, STERILE WATER & NORMAL SALINE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Nurse Assist, Inc. (Carrollton, US). The FDA issued a Cleared decision on December 18, 2008 after a review of 65 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 - K083042

510(k) Number K083042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date December 18, 2008
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
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 652
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K083042.
KERATEC WOUND DRESSINGS
K080949 · Keratec Limited · Feb 2009
PRUMYX CREAM
K082089 · Prugen, Inc. · Jan 2009
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
K083355 · Blairex Laboratories, Inc. · Dec 2008
PROSIT WOUND TREATMENT DEVICE
K081977 · Silverleaf Medical Products, Inc. · Dec 2008
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
K080503 · Advanced Medical Solutions Limited · Nov 2008
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
K082330 · Primary Care Solutions, Inc. · Oct 2008
K083042 · WOUND FLUSH, STERILE WATER & NORMAL SALINE
Download PDF FDA Summary Nurse Assist, Inc.