Cleared Traditional

K163144 - gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) (FDA 510(k) Clearance)

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

K163144 · Gke-GmbH · General Hospital
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Apr 2017
Decision
149d
Days
Class 2
Risk

K163144 is an FDA 510(k) clearance for the gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI). Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Gke-GmbH (Waldems, DE). The FDA issued a Cleared decision on April 7, 2017 after a review of 149 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 Gke-GmbH devices

Submission Details

510(k) Number K163144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2016
Decision Date April 07, 2017
Days to Decision 149 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
21d slower than avg
Panel avg: 128d · This submission: 149d
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

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