Cleared Traditional

K220564 - 3M Comply Lead Free Steam Indicator Tap...

K220564 is the FDA 510(k) clearance for 3M Comply Lead Free Steam Indicator Tap... by 3M Company. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K220564 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
84d
Days
Class 2
Risk

K220564 is an FDA 510(k) clearance for the 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indi.... 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 May 23, 2022 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K220564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2022
Decision Date May 23, 2022
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 K220564.
3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
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K212592 · Propper Manufacturing Co., Inc. · Jan 2022
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K212081 · 3M Company · Sep 2021