Cleared Traditional

K925745 - ATI(R) DISP BIOLOGICAL-PLUS TEST PACK

K925745 is an FDA 510(k) clearance for ATI DISP BIOLOGICAL-PLUS TEST PACK, 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 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.

FDA 510(k) Submission Details - K925745

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
Combination Product No
PCCP Authorized No
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.

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 205
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K925745.
ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR
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EZTEST-STEAM
K930682 · Sgm Biotech, Inc. · Apr 1994
ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK
K925496 · Pymah Corp. · Feb 1994
STERRAD BI TEST PACK
K921909 · Johnson & Johnson Medical, Inc. · Oct 1993
MDT CASTLE BIOSIGN TEST PACK
K922212 · Mdt Corp., Inc. · Aug 1992
SPORE STRIP
K912796 · Raven Biological Laboratories, Inc. · Apr 1992
K925745 · ATI(R) DISP BIOLOGICAL-PLUS TEST PACK
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