Cleared Traditional

K202879 - EOGas 4 Endo-SteriTest RRBI

K202879 is an FDA 510(k) clearance for EOGas 4 Endo-SteriTest RRBI, manufactured by Andersen Sterilizers, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K202879 · Andersen Sterilizers, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
156d
Days
Class 2
Risk

K202879 is an FDA 510(k) clearance for the EOGas 4 Endo-SteriTest RRBI. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Andersen Sterilizers, Inc. (Haw River, US). The FDA issued a Cleared decision on March 3, 2021 after a review of 156 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 Andersen Sterilizers, Inc. devices

FDA 510(k) Submission Details - K202879

510(k) Number K202879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date March 03, 2021
Days to Decision 156 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 129d · This submission: 156d
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 135
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K202879.
CELERITY 20 HP Challenge Pack
K220473 · Steris · Mar 2022
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
K212193 · Plasmapp Co,., Ltd. · Oct 2021
STERIZONE VP4 Test Pack
K203560 · Tso3 Inc., Now A Part of Stryker · Mar 2021
3M Attest Rapid Readout Biological Indicator, 1295
K210277 · 3M Company · Mar 2021
Celerity 20 Steam Biological Indicator for IUSS
K202721 · STERIS Corporation · Jan 2021
Self-Contained Biological Indicator
K200970 · True Indicating, LLC · Dec 2020