Cleared Traditional

K172432 - SporView Rapid Read Biological Indicator

K172432 is the FDA 510(k) clearance for SporView Rapid Read Biological Indicator by Crosstex/Spsmedical, A Division of Cantel Medical. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K172432 · Crosstex/Spsmedical, A Division of Cantel Medical · General Hospital
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Dec 2017
Decision
123d
Days
Class 2
Risk

K172432 is an FDA 510(k) clearance for the SporView Rapid Read Biological Indicator. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Crosstex/Spsmedical, A Division of Cantel Medical (Rush, US). The FDA issued a Cleared decision on December 12, 2017 after a review of 123 days - within the typical 510(k) review window.

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 Crosstex/Spsmedical, A Division of Cantel Medical devices

Submission Details

510(k) Number K172432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2017
Decision Date December 12, 2017
Days to Decision 123 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
6d faster than avg
Panel avg: 129d · This submission: 123d
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 115
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K172432.
Sporview VH202 BI
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3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader
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Celerity 20 HP Biological Indicator
K172474 · STERIS Corporation · Dec 2017
VERIFY Assert VH2O2 Self-Contained Biological Indicator
K171504 · STERIS Corporation · Aug 2017
VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
K171587 · STERIS Corporation · Aug 2017
3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
K171003 · 3M Company · Jul 2017