Cleared Special

K001444 - STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103

K001444 is an FDA 510(k) clearance for STERITEC STEAM BIOLOGICAL TEST PACK WIT..., manufactured by Steritec Products, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Special 510(k) pathway after a 7-day FDA review.

K001444 · Steritec Products, Inc. · General Hospital
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May 2000
Decision
7d
Days
Class 2
Risk

K001444 is an FDA 510(k) clearance for the STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI.... 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 May 15, 2000 after a review of 7 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K001444

510(k) Number K001444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2000
Decision Date May 15, 2000
Days to Decision 7 days
Submission Type Special
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
122d faster than avg
Panel avg: 129d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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 K001444.
EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124
K002861 · Steritec Products, Inc. · Nov 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
STEAM/EO RECORD CARD, MODEL CI 121
K000502 · Steritec Products Mfg Co, Inc. · Mar 2000
BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K992767 · Albert Browne , Ltd. · Jan 2000
CIDEX OPA SOLUTION TEST STRIP
K992341 · Serim Research Corp. · Nov 1999
K001444 · STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
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