Data / Medical devices / United States / True Indicating LLC
True Indicating LLC: FDA-registered device maker in Toledo, OH, United States, 5 510(k) clearances
True Indicating LLC is registered with the FDA (registration 3017524825) in Toledo, OH, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017524825
- Address
- 946 Kane St Suite A, Toledo, OH, United States, 43612
- Owner or operator
- True Indicating LLC (10079928)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 4, 2021
- Registered through
- 2026
- Brand names listed
- ISCS-05E, InstaTRU Instant Biological Indicator for Steam, Instant 20s Indicator, MSCS-05E, MSCST-05L, MSCST-05SF, SBI-100, SRI-050 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biological Sterilization Indicator With Indirect Growth Detection | QVB | 2 | Manufacturer | accessdata.fda.gov |
| Indicator, Biological Sterilization Process | FRC | 2 | Manufacturer | accessdata.fda.gov |
| Indicator, Chemical, Enzymatic, Sterilization Process | MTC | 2 | Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2026 | K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | QVB | Substantially Equivalent | True Indicating, LLC | accessdata.fda.gov |
| January 17, 2025 | K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | JOJ | Substantially Equivalent | True Indicating, LLC | accessdata.fda.gov |
| December 14, 2021 | K210481 | Instant 20s Indicator | MTC | Substantially Equivalent | True Indicating, LLC | accessdata.fda.gov |
| December 28, 2020 | K200970 | Self-Contained Biological Indicator | FRC | Substantially Equivalent | True Indicating, LLC | accessdata.fda.gov |
| February 22, 2018 | K171823 | U&U Indicator tape and strip | JOJ | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Biological Sterilization Process
- All makers of Indicator, Physical/Chemical Sterilization Process
Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.