Cleared Traditional

K925745 - ATI DISP BIOLOGICAL-PLUS TEST PACK

K925745 is the FDA 510(k) clearance for ATI DISP BIOLOGICAL-PLUS TEST PACK by Pymah Corp.. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K925745 · Pymah Corp. · General Hospital
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Feb 1994
Decision
445d
Days
Class 2
Risk

K925745 is an FDA 510(k) clearance for the ATI(R) DISP BIOLOGICAL-PLUS TEST PACK. 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 February 1, 1994 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Pymah Corp. devices

Submission Details

510(k) Number K925745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1992
Decision Date February 01, 1994
Days to Decision 445 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 129d · This submission: 445d
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 K925745.
STERRAD BI TEST PACK
K993775 · Advanced Sterilization Products · Jun 2000
MODIFICATION OF: STERRAD BI TEST PACK
K991675 · Advanced Sterilization Products · Jun 1999
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