510(k) K251559
- Device
- InstaTRU Instant Biological Indicator for Steam (IBI-05)
- Applicant
- True Indicating, LLC
- 510(k) number
- K251559
- Product code
- QVB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-18
- Date received
- 2025-05-21
- Regulation
- 880.2806
- Classification name
- Biological Sterilization Indicator With Indirect Growth Detection
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Thomas Riha
- Address
- 946 Kane St. Toledo OH US 43551 43551
FDA Registration Numbers#
- 3015392401
- 3013145340
Source Documents#
Other 510(k) Records For Product Code QVB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252306 | 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) | Steritec Products | 2026-04-22 |
| DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | Terragene S.A. | 2024-07-12 |