Cleared Traditional

3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR (K013228) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013228 · Minnesota Mining and Mfg. Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
113d
Days
Class 2
Risk

K013228 is an FDA 510(k) clearance for the 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Minnesota Mining and Mfg. Co. (Minneapolis, US). The FDA issued a Cleared decision on January 18, 2002 after a review of 113 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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.

View all Minnesota Mining and Mfg. Co. devices

Submission Details

510(k) Number K013228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2001
Decision Date January 18, 2002
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
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 97
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K013228.
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
K070461 · STERIS Corporation · Jul 2007
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · STERIS Corporation · Dec 2004
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company · Apr 2002
3M AUTOCLAVE TAPES
K932129 · 3M Company · Mar 1994
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045 · Edward Weck, Inc. · Feb 1990
TOWER SELF SEAL STERILIZATION POUCH
K895422 · Baxter Healthcare Corp · Nov 1989