Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
True Indicating, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
264 daysmedian FDA review time
393 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | 2026-06-18 | 393 | 0 |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | 2025-01-17 | 119 | 0 |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | 2024-06-26 | 264 | 0 |
| K220778 | Chemical Indicator for Steam | True Indicating, LLC | 2022-12-02 | 260 | 0 |
| K210481 | Instant 20s Indicator | True Indicating, LLC | 2021-12-14 | 298 | 0 |
| K200970 | Self-Contained Biological Indicator | True Indicating, LLC | 2020-12-28 | 259 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda