Cleared Abbreviated

K122555 - STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE

K122555 is an FDA 510(k) clearance for STERITEC LEAD FREE STERILIZATION PROCES..., manufactured by Steritec Products Mfg Co, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Abbreviated 510(k) pathway after a 112-day FDA review.

K122555 · Steritec Products Mfg Co, Inc. · General Hospital
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Dec 2012
Decision
112d
Days
Class 2
Risk

K122555 is an FDA 510(k) clearance for the STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steritec Products Mfg Co, Inc. (Engelwood, US). The FDA issued a Cleared decision on December 12, 2012 after a review of 112 days - within the typical 510(k) review window.

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.

View all Steritec Products Mfg Co, Inc. devices

FDA 510(k) Submission Details - K122555

510(k) Number K122555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2012
Decision Date December 12, 2012
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 217
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