FDA 510(k)

Terragene® Bionova® BT20 Biological Indicator

K-Number: K251122 · 2025-08-04

Decision Date2025-08-04

Product CodeFRC

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Terragene® Bionova® BT20 Biological Indicator is a medical device manufactured by Terragene. It received FDA 510(k) clearance on 2025-08-04 under approval number K251122. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Terragene® Bionova® BT20 Biological Indicator?

Terragene® Bionova® BT20 Biological Indicator is a medical device that received FDA 510(k) clearance on 2025-08-04. It is manufactured by Terragene. The 510(k) number is K251122.

When was Terragene® Bionova® BT20 Biological Indicator approved by the FDA?

Terragene® Bionova® BT20 Biological Indicator received FDA 510(k) clearance on 2025-08-04, under approval number K251122.

What company makes Terragene® Bionova® BT20 Biological Indicator?

Terragene® Bionova® BT20 Biological Indicator is manufactured by Terragene.

What is the FDA product code for Terragene® Bionova® BT20 Biological Indicator?

The FDA product code for Terragene® Bionova® BT20 Biological Indicator is FRC.

Related Devices (Code: FRC)

K1605463M Attest Rapid Readout Biological Indicator3M Company K151482BCR-30-min BI and RBIP-ST30 Readout AccessoryBcr Diagnostics, Inc. K172474Celerity 20 HP Biological IndicatorSTERIS Corporation K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A. K170427Anprolene SteriTestAndersen Sterilizers, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.