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FDA 510(k)

InstaTRU Instant Biological Indicator for Steam (IBI-05)

K-Number: K251559 · 2026-06-18

ApplicantTrue Indicating, LLC
Decision Date2026-06-18
Product CodeQVB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

InstaTRU Instant Biological Indicator for Steam (IBI-05) is the device name listed in this FDA 510(k) record. The listed applicant is True Indicating, LLC. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K251559. The device is classified under product code QVB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InstaTRU Instant Biological Indicator for Steam (IBI-05)?

InstaTRU Instant Biological Indicator for Steam (IBI-05) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is True Indicating, LLC. The 510(k) number is K251559.

When did InstaTRU Instant Biological Indicator for Steam (IBI-05) receive FDA 510(k) clearance?

InstaTRU Instant Biological Indicator for Steam (IBI-05) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K251559.

Who is the listed applicant for InstaTRU Instant Biological Indicator for Steam (IBI-05)?

The FDA 510(k) record lists True Indicating, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InstaTRU Instant Biological Indicator for Steam (IBI-05)?

The FDA product code for InstaTRU Instant Biological Indicator for Steam (IBI-05) is QVB.

Other records listing True Indicating, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242860Type 5 Integrating Indicator for Steam (CSPN-15)K233413Ultraphon Chemical Indicator (TRO-T and TRO-B)K220778Chemical Indicator for SteamK210481Instant 20s IndicatorK200970Self-Contained Biological Indicator

Related Devices (Code: QVB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252306Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)Steritec Products

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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