Cleared Traditional

K181434 - SporView Rapid Read Biological Indicator SteamPlus Test Pack (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181434 · Crosstex/Spsmedical, A Division of Cantel Medical · General Hospital
Nov 2018
Decision
166d
Days
Class 2
Risk

K181434 is an FDA 510(k) clearance for the SporView Rapid Read Biological Indicator SteamPlus Test Pack. 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 November 14, 2018 after a review of 166 days - an extended review cycle.

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.

Submission Details

510(k) Number K181434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2018
Decision Date November 14, 2018
Days to Decision 166 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 170d · This submission: 166d
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 22
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