Cleared Traditional

K932129 - 3M AUTOCLAVE TAPES

K932129 is the FDA 510(k) clearance for 3M AUTOCLAVE TAPES by 3M Company. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K932129 · 3M Company · General Hospital
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Mar 1994
Decision
305d
Days
Class 2
Risk

K932129 is an FDA 510(k) clearance for the 3M AUTOCLAVE TAPES. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on March 4, 1994 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K932129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1993
Decision Date March 04, 1994
Days to Decision 305 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 129d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 114
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K932129.
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company · Apr 2002
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
K974415 · Kimberly-Clark Corp. · Jul 1998
STERRAD CHEMICAL INDICATOR TAPE
K945190 · Advanced Sterilization Products · Dec 1994
STERRAD CHEMICAL INDICATOR
K921910 · Johnson & Johnson Medical, Inc. · Oct 1993
CHEMDI-VHP CHEMICAL INDICATOR
K922485 · American Sterilizer Co. · Sep 1993
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045 · Edward Weck, Inc. · Feb 1990