Cleared Traditional

K952995 - ATI ETHYLENE OXIDE STERILIZATION INDICATOR

K952995 is an FDA 510(k) clearance for ATI ETHYLENE OXIDE STERILIZATION INDICATOR, manufactured by Pymah Corp.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K952995 · Pymah Corp. · General Hospital
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Feb 1996
Decision
239d
Days
Class 2
Risk

K952995 is an FDA 510(k) clearance for the ATI ETHYLENE OXIDE STERILIZATION INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Pymah Corp. (Flemington, US). The FDA issued a Cleared decision on February 22, 1996 after a review of 239 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.

View all Pymah Corp. devices

FDA 510(k) Submission Details - K952995

510(k) Number K952995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1995
Decision Date February 22, 1996
Days to Decision 239 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
110d slower than avg
Panel avg: 129d · This submission: 239d
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 218
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K952995.
CROSS-CHECKS EO GAS STERILIZATION MONITOR
K952244 · Steritec Products Mfg Co, Inc. · Aug 1996
PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR
K960089 · Cottrell, Ltd. · Apr 1996
STERITEC CROSS-CHECKS
K955426 · Steritec Products Mfg Co, Inc. · Mar 1996
ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
K952408 · Pymah Corp. · Jul 1995
ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION
K951063 · Pymah Corp. · May 1995
STERIGAGE EO 100%
K934874 · Pymah Corp. · Apr 1995