Cleared Traditional

K231383 - Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (FDA 510(k) Clearance)

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

K231383 · Terragene S.A. · General Hospital
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Sep 2024
Decision
495d
Days
Class 2
Risk

K231383 is an FDA 510(k) clearance for the Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bi.... 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 September 18, 2024 after a review of 495 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Terragene S.A. devices

Submission Details

510(k) Number K231383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2023
Decision Date September 18, 2024
Days to Decision 495 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
367d slower than avg
Panel avg: 128d · This submission: 495d
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 Consultant

Licensale, Inc.
Raymond Kelly

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRC Indicator, Biological Sterilization Process

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