# True Indicating, LLC

- Location (FDA's records): Toledo, OH
- FDA decisions: 6 (2020–2026): 6 510(k) clearances
- Product codes: JOJ (3), FRC (1), MTC (1), QVB (1)
- 510(k) review time since 2016: median 260 days, against 90 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terragene S.A.: 2 (https://510kreport.com/company/terragene)
- Spsmedical Supply Corp.: 1 (https://510kreport.com/company/spsmedical-supply)
- North American Science Assoc., Inc.: 1 (https://510kreport.com/company/north-american-science-assoc)
- Nanosonics Limited: 1 (https://510kreport.com/company/nanosonics)
- Kem Medical Products Corp.: 1 (https://510kreport.com/company/kem-medical-products)

## Recent decisions
- K251559: InstaTRU Instant Biological Indicator for Steam (IBI-05) (Jun 18, 2026)
- K242860: Type 5 Integrating Indicator for Steam (CSPN-15) (Jan 17, 2025)
- K233413: Ultraphon Chemical Indicator (TRO-T and TRO-B) (Jun 26, 2024)
- K220778: Chemical Indicator for Steam (Dec 2, 2022)
- K210481: Instant 20s Indicator (Dec 14, 2021)
- K200970: Self-Contained Biological Indicator (Dec 28, 2020)

Source page: https://510kreport.com/company/true-indicating