Cleared Traditional

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) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252306 · Steritec Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
272d
Days
Class 2
Risk

K252306 is an FDA 510(k) clearance for the Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM .... Classified as Biological Sterilization Indicator With Indirect Growth Detection (product code QVB), Class II - Special Controls.

Submitted by Steritec Products (Engelwood, US). The FDA issued a Cleared decision on April 22, 2026 after a review of 272 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2806 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Steritec Products devices

Submission Details

510(k) Number K252306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2025
Decision Date April 22, 2026
Days to Decision 272 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 128d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QVB Biological Sterilization Indicator With Indirect Growth Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2806
Definition A Biological Sterilization Indicator With Indirect Growth Detection Capabilities Is A Device Intended For Use By A Healthcare Provider To Accompany Products Being Sterilized Through A Sterilization Process To Monitor The Adequacy Of Sterilization. Detection Of Surviving Microorganisms Is Accomplished By A Method Other Than Direct Detection Of Growth Or Growth Products.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Getinge
Barb Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.