Medical Device Manufacturer · US , Toledo , OH

True Indicating, LLC - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2020

Recent clearances: Type 5 Integrating Indicator for Steam (CSPN-15), Ultraphon Chemical Indicator (TRO-T and TRO-B), Chemical Indicator for Steam

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - True Indicating, LLC General Hospital ✕

5 devices

1-5 of 5

Cleared Jun 18, 2026

InstaTRU Instant Biological Indicator for Steam (IBI-05)

General Hospital · 393d

Cleared Jan 17, 2025

Type 5 Integrating Indicator for Steam (CSPN-15)

General Hospital · 119d

Cleared Jun 26, 2024

Ultraphon Chemical Indicator (TRO-T and TRO-B)

General Hospital · 264d

Cleared Dec 02, 2022

Chemical Indicator for Steam

General Hospital · 260d

Cleared Dec 28, 2020

Self-Contained Biological Indicator

General Hospital · 259d