Cleared Traditional

K150622 - 3M Comply Hydrogen Peroxide Chemical In...

K150622 is the FDA 510(k) clearance for 3M Comply Hydrogen Peroxide Chemical In... by 3M Company. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K150622 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
202d
Days
Class 2
Risk

K150622 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 September 29, 2015 after a review of 202 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

Submission Details

510(k) Number K150622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2015
Decision Date September 29, 2015
Days to Decision 202 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
73d slower than avg
Panel avg: 129d · This submission: 202d
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 98
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K150622.
VERIFY VH2O2 Indicator Tape
K160485 · STERIS Corporation · Jun 2016
VERIFY STEAM Integrating Indicator
K152630 · STERIS Corporation · May 2016
3M Comply Hydrogen Peroxide Indicator Tape 1228
K150694 · 3M Company · Oct 2015
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization
K150477 · 3M Company · Jul 2015
Revital-Ox RESERT Solution Test Strip
K143333 · STERIS Corporation · Apr 2015
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
K140515 · STERIS Corporation · Jul 2014