Cleared Traditional

Andersen EOGas 4 SteriTest (K151585) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151585 · Andersen Sterilizers, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
160d
Days
Class 2
Risk

K151585 is an FDA 510(k) clearance for the Andersen EOGas 4 SteriTest. 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 November 18, 2015 after a review of 160 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

Submission Details

510(k) Number K151585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2015
Decision Date November 18, 2015
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 129d · This submission: 160d
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 89
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K151585.
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
K170070 · STERIS Corporation · Apr 2017
3M Attest Rapid Readout Biological Indicator
K160546 · 3M Company · Jun 2016
3M Attest Rapid Readout Biological Indicator 1295
K152060 · 3M Company · Dec 2015
3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER
K140392 · 3M Company · Aug 2014
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES
K140499 · STERIS Corporation · Jul 2014
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
K140708 · STERIS Corporation · Jun 2014