Cleared Traditional

K000355 - 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR

K000355 is an FDA 510(k) clearance for 3M COMPLY 1249 LIQUID PERACETIC ACID CH..., manufactured by Minnesota Mining and Mfg. Co.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K000355 · Minnesota Mining and Mfg. Co. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
201d
Days
Class 2
Risk

K000355 is an FDA 510(k) clearance for the 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Minnesota Mining and Mfg. Co. (St. Paul, US). The FDA issued a Cleared decision on August 23, 2000 after a review of 201 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.

FDA 510(k) Submission Details - K000355

510(k) Number K000355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date August 23, 2000
Days to Decision 201 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
72d slower than avg
Panel avg: 129d · This submission: 201d
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 247
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K000355.
CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
K003533 · Steritec Products, Inc. · Feb 2001
STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
K003002 · Steritec Products, Inc. · Dec 2000
EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124
K002861 · Steritec Products, Inc. · Nov 2000
STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234
K001649 · Steritec Products, Inc. · Jun 2000
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
K001444 · Steritec Products, Inc. · May 2000
STEAM/EO RECORD CARD, MODEL CI 121
K000502 · Steritec Products Mfg Co, Inc. · Mar 2000
K000355 · 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
Download PDF FDA Summary Minnesota Mining and …