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FDA 510(k)

Type 5 Integrating Indicator for Steam (CSPN-15)

K-Number: K242860 · 2025-01-17

ApplicantTrue Indicating, LLC
Decision Date2025-01-17
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Type 5 Integrating Indicator for Steam (CSPN-15) 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 2025-01-17 under 510(k) number K242860. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Type 5 Integrating Indicator for Steam (CSPN-15)?

Type 5 Integrating Indicator for Steam (CSPN-15) is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is True Indicating, LLC. The 510(k) number is K242860.

When did Type 5 Integrating Indicator for Steam (CSPN-15) receive FDA 510(k) clearance?

Type 5 Integrating Indicator for Steam (CSPN-15) received FDA 510(k) clearance on 2025-01-17, under 510(k) number K242860.

Who is the listed applicant for Type 5 Integrating Indicator for Steam (CSPN-15)?

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 Type 5 Integrating Indicator for Steam (CSPN-15)?

The FDA product code for Type 5 Integrating Indicator for Steam (CSPN-15) is JOJ.

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.

K251559InstaTRU Instant Biological Indicator for Steam (IBI-05)K233413Ultraphon Chemical Indicator (TRO-T and TRO-B)K220778Chemical Indicator for SteamK210481Instant 20s IndicatorK200970Self-Contained Biological Indicator

Related Devices (Code: JOJ)

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.

K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS CorporationK250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)

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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