Cleared Traditional

K894398 - STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE

K894398 is an FDA 510(k) clearance for STERIGAGE INTEGRATOR TEST PACK FOR ETHY..., manufactured by Pymah Corp.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K894398 · Pymah Corp. · General Hospital
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Sep 1989
Decision
56d
Days
Class 2
Risk

K894398 is an FDA 510(k) clearance for the STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Pymah Corp. (No. Hollywood, US). The FDA issued a Cleared decision on September 11, 1989 after a review of 56 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.

View all Pymah Corp. devices

FDA 510(k) Submission Details - K894398

510(k) Number K894398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date September 11, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRC Device Classification - Class 2, Special Controls

Product Code FRC Indicator, Biological 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 - FRC Indicator, Biological Sterilization Process

All 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K894398.
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · 3M Company · Jul 1990
BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR
K891784 · Propper Mfg. Co., Inc. · Feb 1990
SPORVIEW CULTURE MEDIA
K890754 · Spsmedical Supply Corp. · Nov 1989
STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.
K894399 · Pymah Corp. · Sep 1989
BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.)
K891366 · Mdt Corp., Inc. · Mar 1989
ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.
K863122 · Surgicot, Inc. · Dec 1986