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)— 510(k) K252306
Substantially EquivalentSteritec Products
FDA 510(k) clearance K252306 for 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), Substantially Equivalent on 2026-04-22. Applicant: Steritec Products. Device class: 2.
Summary
Steritec Products' record covers three Verrix EVA items under one name: the STEAM Biological Indicator (model 1200) and STEAM Process Challenge Device (model 1300), combined with the Verrix EVA Auto-Reader (model 1100). They're filed under product code QVB (Biological Sterilization Indicator With Indirect Growth Detection).
Class II, 21 CFR 880.2806. It came in as a Traditional 510(k), and General Hospital is both the classification panel and the review panel.
Steritec Products filed from Engelwood, Colorado. Review took 272 calendar days (July 24, 2025 to April 22, 2026).
Clearance details
- Applicant
- Steritec Products
- Product code
- Product code QVB
- Device class
- Class 2
- Regulation
- 21 CFR 880.2806
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Engelwood, CO, US
Recent devices under product code QVB
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