Not Cleared Post-NSE

VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR (DEN110006) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN110006 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
675d
Days
Class 2
Risk

DEN110006 is an FDA 510(k) submission (not cleared) for the VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR. Classified as Biological Sterilization Process Indicator With Recombinant-dna Plasmid (product code OWP), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Not Cleared (DENG) decision on July 12, 2013 after a review of 675 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2805 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 675 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all STERIS Corporation devices

Submission Details

510(k) Number DEN110006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 06, 2011
Decision Date July 12, 2013
Days to Decision 675 days
Submission Type Post-NSE
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
546d slower than avg
Panel avg: 129d · This submission: 675d
Pathway characteristics

Device Classification

Product Code OWP Biological Sterilization Process Indicator With Recombinant-dna Plasmid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2805
Definition A Recombinant-dna Plasmid Biological Indicator Is Intended For Use By A Health Care Provider To Accompany Products Being Sterilized Through A Sterilization Procedure And To Monitor Adequacy Of Sterilization.
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 - OWP Biological Sterilization Process Indicator With Recombinant-dna Plasmid

Devices cleared under the same product code (OWP) and FDA review panel - the closest regulatory comparables to DEN110006.
VERIFY Assert Self-Contained Biological Indicator
K181442 · STERIS Corporation · Jun 2018
VERIFY ASSERT STEAM Process Challenge Device
K162945 · STERIS Corporation · Apr 2017
VERIFY Assert Self-Contained Biological Indicator
K162701 · STERIS Corporation · Mar 2017
VERIFY Incubator for Assert Self Contained Biological Indicators
K163587 · STERIS Corporation · Mar 2017