Cleared Traditional

K930632 - CHEMOSITE IMPLANTABLE DRUG DELIVERY

K930632 is an FDA 510(k) clearance for CHEMOSITE IMPLANTABLE DRUG DELIVERY, manufactured by Device Labs, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K930632 · Device Labs, Inc. · General & Plastic Surgery device
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Dec 1993
Decision
317d
Days
Class 1
Risk

K930632 is an FDA 510(k) clearance for the CHEMOSITE IMPLANTABLE DRUG DELIVERY. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Device Labs, Inc. (Medway, US). The FDA issued a Cleared decision on December 22, 1993 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Device Labs, Inc. devices

FDA 510(k) Submission Details - K930632

510(k) Number K930632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1993
Decision Date December 22, 1993
Days to Decision 317 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 115d · This submission: 317d
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 157
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K930632.
ALLKARE BARRIER WIPE
K925004 · Convatec, A Division of E.R. Squibb & Sons · Jan 1994
BRENNEN MEDICAL STERILE SALINE SOLUTION
K935060 · Brennen Medical, Inc. · Jan 1994
EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN
K926230 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING
K933689 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1993
DUODERM EXTRA THIN CGF DRESSING
K925990 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
K925991 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993