Cleared Traditional

K170321 - 3M Comply Hydrogen Peroxide Chemical In...

K170321 is an FDA 510(k) clearance for 3M Comply Hydrogen Peroxide Chemical In..., manufactured by 3M Company. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K170321 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
194d
Days
Class 2
Risk

K170321 is an FDA 510(k) clearance for the 3M Comply Hydrogen Peroxide Chemical Indicator 1248. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on August 14, 2017 after a review of 194 days - an extended review cycle.

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 3M Company devices

FDA 510(k) Submission Details - K170321

510(k) Number K170321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2017
Decision Date August 14, 2017
Days to Decision 194 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
65d slower than avg
Panel avg: 129d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

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 191
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K170321.
Micro-MEC 1.8% Glutaraldehyde Monitor Strip
K172472 · STERIS Corporation · Nov 2017
AN87 Dosimeter
K170439 · Andersen Sterilizers, Inc. · Nov 2017
AN85/AN86 EO Indicators
K170426 · Andersen Sterilizers, Inc. · Oct 2017
3M Comply Hydrogen Peroxide Indicator Tape
K170563 · 3M Company · Jul 2017
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
K162758 · STERIS Corporation · Mar 2017
VERIFY STEAM Integrating Indicator - Short
K162631 · STERIS Corporation · Jan 2017