Cleared Traditional

K894399 - STERIGAGE INTEGRATOR TEST PACK FOR STEA...

K894399 is the FDA 510(k) clearance for STERIGAGE INTEGRATOR TEST PACK FOR STEA... by Pymah Corp.. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K894399 · Pymah Corp. · General Hospital
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Sep 1989
Decision
56d
Days
Class 2
Risk

K894399 is an FDA 510(k) clearance for the STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Pymah Corp. (Somerville, 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

Submission Details

510(k) Number K894399 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
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.

Device Classification

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 115
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K894399.
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · 3M Health Care, Ltd. · Mar 1995
STERRAD BI TEST PACK
K921909 · Johnson & Johnson Medical, Inc. · Oct 1993
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · 3M Company · Jul 1990
ATI DISPOSABLE BIOLOGICAL TEST PACK
K855120 · Parke-Davis Co. · Jun 1986
CHEMSPOR
K844479 · American Sterilizer Co. · Nov 1985
DISPOSABLE STEAM BIOLOGICAL TEST PACK
K852192 · Parke-Davis Co. · Nov 1985