Cleared Traditional

K172432 - SporView Rapid Read Biological Indicator

K172432 is an FDA 510(k) clearance for SporView Rapid Read Biological Indicator, manufactured by Crosstex/Spsmedical, A Division of Cantel Medical. The device is a Class 2 General Hospital device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K172432

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
Combination Product No
PCCP Authorized No
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.

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 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K172432.
Sporview VH202 BI
K171287 · Spsmedical Supply Corp. A Division of Cantel Medical · Feb 2018
3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader
K173584 · 3M Company · Jan 2018
Celerity 20 HP Biological Indicator
K172474 · STERIS Corporation · Dec 2017
Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator
K163646 · Terragene S.A. · Nov 2017
Anprolene SteriTest
K170427 · Andersen Sterilizers, Inc. · Oct 2017
VERIFY Assert VH2O2 Self-Contained Biological Indicator
K171504 · STERIS Corporation · Aug 2017