Cleared Traditional

K020612 - SULTAN SPOROX TEST VIAL, MODEL 75195

K020612 is an FDA 510(k) clearance for SULTAN SPOROX TEST VIAL, manufactured by Sultan Chemists, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K020612 · Sultan Chemists, Inc. · General Hospital
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May 2002
Decision
71d
Days
Class 2
Risk

K020612 is an FDA 510(k) clearance for the SULTAN SPOROX TEST VIAL, MODEL 75195. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Sultan Chemists, Inc. (Englewood, US). The FDA issued a Cleared decision on May 7, 2002 after a review of 71 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.

FDA 510(k) Submission Details - K020612

510(k) Number K020612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2002
Decision Date May 07, 2002
Days to Decision 71 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 K020612.
STEAMPLUS STERILIZATION TEST
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STEAM STERILIZATION INTERGRATOR
K012195 · Dana Products, Inc. · May 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company · Apr 2002
INTEGRAPH FLASH, MODEL CI 110
K012732 · Steritec Products, Inc. · Mar 2002
3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR
K013228 · Minnesota Mining and Mfg. Co. · Jan 2002
K020612 · SULTAN SPOROX TEST VIAL, MODEL 75195
Download PDF Sultan Chemists, Inc.