Cleared Traditional

K884767 - ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK

K884767 is an FDA 510(k) clearance for ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK, 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 57-day FDA review.

K884767 · Pymah Corp., Ati Div. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
57d
Days
Class 2
Risk

K884767 is an FDA 510(k) clearance for the ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Pymah Corp., Ati Div. (North Hollywood, US). The FDA issued a Cleared decision on January 10, 1989 after a review of 57 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., Ati Div. devices

FDA 510(k) Submission Details - K884767

510(k) Number K884767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date January 10, 1989
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 K884767.
STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE
K894398 · Pymah Corp. · Sep 1989
STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.
K894399 · Pymah Corp. · Sep 1989
BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.)
K891366 · Mdt Corp., Inc. · Mar 1989
ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.
K863122 · Surgicot, Inc. · Dec 1986
ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR
K855101 · Surgicot, Inc. · Jul 1986
ATI DISPOSABLE BIOLOGICAL TEST PACK
K855120 · Parke-Davis Co. · Jun 1986