Cleared Traditional

K902344 - ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER

K902344 is an FDA 510(k) clearance for ATI DISPOSABLE BIOLOGICAL TEST PACK FOR..., manufactured by Ati. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K902344 · Ati · General Hospital
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Jul 1990
Decision
55d
Days
Class 2
Risk

K902344 is an FDA 510(k) clearance for the ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Ati (Potomac, US). The FDA issued a Cleared decision on July 19, 1990 after a review of 55 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 Ati devices

FDA 510(k) Submission Details - K902344

510(k) Number K902344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1990
Decision Date July 19, 1990
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 182
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K902344.
MDT CASTLE BIOSIGN TEST PACK
K922212 · Mdt Corp., Inc. · Aug 1992
SPORVIEW
K905425 · Spsmedical Supply Corp. · Mar 1992
BI-O.K. STEAM TEST-PAK
K903024 · Propper Mfg. Co., Inc. · Sep 1990
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