Cleared Traditional

Terragene? Bionova? BT20 Biological Indicator

K251122 · Terragene · General Hospital
Aug 2025
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K251122 is an FDA 510(k) clearance for the Terragene? Bionova? BT20 Biological Indicator, a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by Terragene (Alvear, AR). The FDA issued a Cleared decision on August 4, 2025, 115 days after receiving the submission on April 11, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K251122 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date August 04, 2025
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRC — Indicator, Biological Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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