Cleared Special

K032723 - BIOSIGN STEAM-24 BIOLOGICAL INDICATOR

K032723 is an FDA 510(k) clearance for BIOSIGN STEAM-24 BIOLOGICAL INDICATOR, manufactured by Getinge USA, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Special 510(k) pathway after a 28-day FDA review.

K032723 · Getinge USA, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
28d
Days
Class 2
Risk

K032723 is an FDA 510(k) clearance for the BIOSIGN STEAM-24 BIOLOGICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Getinge USA, Inc. (Rochester, US). The FDA issued a Cleared decision on October 1, 2003 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Getinge USA, Inc. devices

FDA 510(k) Submission Details - K032723

510(k) Number K032723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2003
Decision Date October 01, 2003
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 167
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K032723.
STERRAD NX CHALLENGE PACK
K042450 · Advanced Sterilization Products · May 2005
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
K041099 · Spsmedical Supply Corp. · May 2004
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294
K031012 · 3M Company · Oct 2003
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K031226 · Advanced Sterilization Products · May 2003
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
K023716 · Spsmedical Supply Corp. · Dec 2002
SPSMEDICAL SPORVIEW STEAM BI TEST PACK
K022706 · Spsmedical Supply Corp. · Oct 2002