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FDA 510(k)

Terragene® Bionova® BT20 Biological Indicator

K-Number: K251122 · 2025-08-04

ApplicantTerragene
Decision Date2025-08-04
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Terragene® Bionova® BT20 Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Terragene. It received FDA 510(k) clearance on 2025-08-04 under 510(k) 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. The listed applicant is Terragene. The 510(k) number is K251122.

When did Terragene® Bionova® BT20 Biological Indicator receive FDA 510(k) clearance?

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

Who is the listed applicant for Terragene® Bionova® BT20 Biological Indicator?

The FDA 510(k) record lists Terragene as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250061Celerity IncubatorSTERIS CorporationK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M3M Company

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.

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