Cleared Traditional

K030574 - GLUSEAL 5ML DISPENSER

K030574 is an FDA 510(k) clearance for GLUSEAL 5ML DISPENSER, manufactured by Glustitch, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K030574 · Glustitch, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
178d
Days
Class 1
Risk

K030574 is an FDA 510(k) clearance for the GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Glustitch, Inc. (Delta, CA). The FDA issued a Cleared decision on August 21, 2003 after a review of 178 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Glustitch, Inc. devices

FDA 510(k) Submission Details - K030574

510(k) Number K030574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2003
Decision Date August 21, 2003
Days to Decision 178 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
63d slower than avg
Panel avg: 115d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 92
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K030574.
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
K051082 · Medtrade Products , Ltd. · Nov 2005
RESTORE WOUND CLEANSER
K040779 · Hollister, Inc. · May 2004
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company · Oct 2003
FERRIS POLYOSTOMY STERILE WOUND DRESSING
K991729 · Ferris Mfg. Corp. · Aug 1999
DYNAREX DRAIN SPONGE
K991694 · Dynarex Corp. · Jul 1999
DYNAREX NON-WOVEN SPONGE
K991695 · Dynarex Corp. · Jul 1999