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.

View all Techstyles devices

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 32
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K920153.
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
K936226 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1994
INSTRUMENT ORGANIZER
K914960 · O.R. Concepts, Inc. · Feb 1992
DISPOSABLE INTRODUCER SHEATH
K910079 · Applied Vascular Devices, Inc. · Feb 1991
BRADLEY TENACULUM HOLDER
K903649 · Marlo Surgical Technology · Nov 1990
RICHARD-ALLAN VESSEL LOOPS
K900566 · Richard-Allan Medical Ind., Inc. · May 1990
INSTRUMENT MAKAR DISPOSALBE LOOP
K853597 · Instrument Makar, Inc. · Sep 1985