Cleared Traditional

K920153 - THERMUFF BAG

K920153 is an FDA 510(k) clearance for THERMUFF BAG, manufactured by Techstyles. The device is a Class 1 General & Plastic Surgery device with product code KDC cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K920153 · Techstyles · General & Plastic Surgery device
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Jul 1992
Decision
170d
Days
Class 1
Risk

K920153 is an FDA 510(k) clearance for the THERMUFF BAG. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Techstyles (Dallas, US). The FDA issued a Cleared decision on July 1, 1992 after a review of 170 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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.

FDA 510(k) Submission Details - K920153

510(k) Number K920153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1992
Decision Date July 01, 1992
Days to Decision 170 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
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

KDC Device Classification - Class 1, General Controls

Product Code KDC Instrument, Surgical, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KDC Instrument, Surgical, Disposable

All 63
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K920153.
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
K943229 · Y.M.K. International Co., Ltd. · Aug 1994
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
K936226 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1994
MANUAL SURGICAL INSTRUMENTS
K920263 · Phoenix Instruments Div. · May 1992
DISPOSABLE CAUTERY ABRASIVE PAD
K915064 · American Medical Mfg., Inc. · Mar 1992
INSTRUMENT ORGANIZER
K914960 · O.R. Concepts, Inc. · Feb 1992
SHUR-GRIP
K912834 · Inman Medical Corp. · Jul 1991
K920153 · THERMUFF BAG
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