Cleared Traditional

K895704 - ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE

K895704 is an FDA 510(k) clearance for ATI DISP. BIOLOGICAL TEST PACK FOR ETHY..., manufactured by Pymah Corp., Ati Div.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K895704 · Pymah Corp., Ati Div. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
167d
Days
Class 2
Risk

K895704 is an FDA 510(k) clearance for the ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Pymah Corp., Ati Div. (Potomac, US). The FDA issued a Cleared decision on March 8, 1990 after a review of 167 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., Ati Div. devices

FDA 510(k) Submission Details - K895704

510(k) Number K895704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1989
Decision Date March 08, 1990
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
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 185
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K895704.
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
STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE
K894398 · Pymah Corp. · Sep 1989