Cleared Special

K023716 - SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP

K023716 is an FDA 510(k) clearance for SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP, manufactured by Spsmedical Supply Corp.. The device is a Class 2 General Hospital device with product code FRC cleared through the Special 510(k) pathway after a 30-day FDA review.

K023716 · Spsmedical Supply Corp. · General Hospital
Download Printable Device Report (PDF)
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Dec 2002
Decision
30d
Days
Class 2
Risk

K023716 is an FDA 510(k) clearance for the SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Spsmedical Supply Corp. (Rush, US). The FDA issued a Cleared decision on December 5, 2002 after a review of 30 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 Spsmedical Supply Corp. devices

FDA 510(k) Submission Details - K023716

510(k) Number K023716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2002
Decision Date December 05, 2002
Days to Decision 30 days
Submission Type Special
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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 123
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K023716.
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 STEAM BI TEST PACK
K022706 · Spsmedical Supply Corp. · Oct 2002
3M ATTEST 290 AUTO-READER
K004009 · 3M Company · Mar 2002
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K994055 · Advanced Sterilization Products · Feb 2002