Cleared Traditional

K251559 - InstaTRU Instant Biological Indicator f...

K251559 is an FDA 510(k) clearance for InstaTRU Instant Biological Indicator f..., manufactured by True Indicating, LLC. The device is a Class 2 General Hospital device with product code QVB cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K251559 · True Indicating, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2026
Decision
393d
Days
Class 2
Risk

K251559 is an FDA 510(k) clearance for the InstaTRU Instant Biological Indicator for Steam (IBI-05). Classified as Biological Sterilization Indicator With Indirect Growth Detection (product code QVB), Class II - Special Controls.

Submitted by True Indicating, LLC (Toledo, US). The FDA issued a Cleared decision on June 18, 2026 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 True Indicating, LLC devices

FDA 510(k) Submission Details - K251559

510(k) Number K251559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2025
Decision Date June 18, 2026
Days to Decision 393 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
264d slower than avg
Panel avg: 129d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QVB Device Classification - Class 2, Special Controls

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 Peers - QVB Biological Sterilization Indicator With Indirect Growth Detection

Devices cleared under the same product code (QVB) and FDA review panel - the closest regulatory comparables to K251559.
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 Products · Apr 2026
Terragene Bionova Photon Biological Indicator (BT225)
DEN220042 · Terragene S.A. · Jul 2024