Cleared Traditional

K221641 - Terragene Bionova Hyper Biological Indi...

K221641 is an FDA 510(k) clearance for Terragene Bionova Hyper Biological Indi..., manufactured by Terragene S.A.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K221641 · Terragene S.A. · General Hospital
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Feb 2023
Decision
267d
Days
Class 2
Risk

K221641 is an FDA 510(k) clearance for the Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hy.... Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on February 28, 2023 after a review of 267 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.

View all Terragene S.A. devices

FDA 510(k) Submission Details - K221641

510(k) Number K221641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date February 28, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 129d · This submission: 267d
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 127
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K221641.
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