Cleared Traditional

InstaTRU Instant Biological Indicator for Steam (IBI-05) (K251559) - FDA 510(k) Clearance

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

K251559 · True Indicating, LLC · General Hospital
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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

Submission Details

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.

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 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