Cleared Abbreviated

K002861 - EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124

K002861 is an FDA 510(k) clearance for EO GAS STERILIZATION PROCESS INDICATOR ..., manufactured by Steritec Products, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Abbreviated 510(k) pathway after a 77-day FDA review.

K002861 · Steritec Products, Inc. · General Hospital
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Nov 2000
Decision
77d
Days
Class 2
Risk

K002861 is an FDA 510(k) clearance for the EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steritec Products, Inc. (Castle Rock, US). The FDA issued a Cleared decision on November 29, 2000 after a review of 77 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K002861

510(k) Number K002861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2000
Decision Date November 29, 2000
Days to Decision 77 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Standards-based clearance path.

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 K002861.
CROSS-CHECKS DUAL, MODEL CI 125
K010534 · Steritec Products, Inc. · Aug 2001
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
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
K000355 · Minnesota Mining and Mfg. Co. · Aug 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
K002861 · EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124
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