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Bionova® Hyper Auto-reader incubator (BHY)

by Terragene S.A.

Bionova® Hyper Auto-reader incubator (BHY) is a Class II device made by Terragene S.A., cleared under FDA 510(k) K221641 on 28 Feb 2023 and listed in FDA GUDID since 6 Mar 2025 (UDI-DI 07798164679103), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K221641

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07798164679103 UDI-DI Date6 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK221641 Date28 Feb 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221641 decided 28 Feb 2023 Active
  • FDA GUDID UDI-DI 07798164679103 listed 6 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221641
  2. Listed FDA GUDID 07798164679103

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bionova®
Generic name
Biological sterilization indicator reader
Model / reference
Hyper Auto-reader incubator (BHY)
Primary DI / UDI-DI
07798164679103
510(k) Number
FDA product code
FRC
GMDN term
Biological sterilization indicator reader
Device class
Class II
Regulation number
880.2800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Biological sterilization indicator reader

Cleared under the same submission (K221641)

Other devices from Terragene S.A.

See all devices from Terragene S.A. →

Properties

  • Contains latex
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)