Cleared Traditional

K900771 - ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR

K900771 is an FDA 510(k) clearance for ATTEST BRAND RAPID READOUT BIOLOGICAL I..., manufactured by 3M Company. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K900771 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
133d
Days
Class 2
Risk

K900771 is an FDA 510(k) clearance for the ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 133 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K900771

510(k) Number K900771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date July 03, 1990
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
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 K900771.
EVIDENCE BIOLOGICAL INDICATOR
K910417 · Skyland Scientific Services, Inc. · Mar 1991
BI-O.K. STEAM TEST-PAK
K903024 · Propper Mfg. Co., Inc. · Sep 1990
ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER
K902344 · Ati · Jul 1990
ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE
K895704 · Pymah Corp., Ati Div. · Mar 1990
BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR
K891784 · Propper Mfg. Co., Inc. · Feb 1990
SPORVIEW CULTURE MEDIA
K890754 · Spsmedical Supply Corp. · Nov 1989
K900771 · ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
Download PDF 3M Company