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

Name: FDA 510(k) clearance K251559
Creator: U.S. Food and Drug Administration
Published: 2026-06-18

Substantially Equivalent

True Indicating, LLC

FDA 510(k) clearance K251559 for InstaTRU Instant Biological Indicator for Steam (IBI-05), Substantially Equivalent on 2026-06-18. Applicant: True Indicating, LLC. Device class: 2.

Summary

True Indicating's InstaTRU Instant Biological Indicator for Steam (IBI-05) is filed under QVB, biological sterilization indicators with indirect growth detection. The record doesn't describe it beyond the model number and the code name.

Class II, 21 CFR 880.2806. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).

True Indicating filed from Toledo, Ohio. Review took 393 calendar days (May 21, 2025 to June 18, 2026).

Clearance details

Applicant: True Indicating, LLC
Product code: Product code QVB
Device class: Class 2
Regulation: 21 CFR 880.2806
Advisory panel: General Hospital
Date received: 2025-05-21
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

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K210481 — Instant 20s Indicator2021-12-14
K200970 — Self-Contained Biological Indicator2020-12-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.