Atlas FDA

InstaTRU Instant Biological Indicator for Steam (IBI-05)

FDA 510(k) clearance K251559 · decided 2026-06-18

Clearance details

K-number
K251559
Device name
InstaTRU Instant Biological Indicator for Steam (IBI-05)
Applicant
True Indicating, LLC
Decision
Substantially Equivalent
Date received
2025-05-21
Decision date
2026-06-18
Days to decision
393 days
Clearance type
Traditional
Product code
QVB
Device class
2
Regulation number
880.2806
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Toledo, OH, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100) (K252306)Steritec Products2026-04-22
Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) (DEN220042)Terragene S.A.2024-07-12

Recalls involving this device

No recalls on record reference this clearance.