True Indicating, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “True Indicating, LLC” (first 2020, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 262 days. Since 2017 the median was 262 days, against 102 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 259 |
| 2021 | 1 | 298 |
| 2022 | 1 | 260 |
| 2023 | 0 | — |
| 2024 | 1 | 264 |
| 2025 | 1 | 119 |
| 2026 | 1 | 393 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name True Indicating, LLC took a median 262 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 3 | 3 |
| FRC | Indicator, Biological Sterilization Process | 1 | 1 |
| MTC | Indicator, Chemical, Enzymatic, Sterilization Process | 1 | 1 |
| QVB | Biological Sterilization Indicator With Indirect Growth Detection | 1 | 1 |
Review panels
- General Hospital (6)
Most recent True Indicating, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | QVB | 2026-06-18 | 393 |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | JOJ | 2025-01-17 | 119 |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | JOJ | 2024-06-26 | 264 |
| K220778 | Chemical Indicator for Steam | JOJ | 2022-12-02 | 260 |
| K210481 | Instant 20s Indicator | MTC | 2021-12-14 | 298 |
| K200970 | Self-Contained Biological Indicator | FRC | 2020-12-28 | 259 |
Recalls
openFDA lists no recalls under a recalling firm named True Indicating, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- True Diagnostics, Inc. (2 510(k)s)
- True Function Laboratory, Inc. (2 510(k)s)
- True Glove Factory (2 510(k)s)
- True Wearables, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under True Indicating, LLC?
FDA lists 6 510(k) clearances under the applicant name “True Indicating, LLC” (first 2020, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by True Indicating, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name True Indicating, LLC is 262 days. Since 2017: 262 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under True Indicating, LLC?
The most frequent FDA product codes under this applicant name are JOJ (Indicator, Physical/Chemical Sterilization Process, 3); FRC (Indicator, Biological Sterilization Process, 1); MTC (Indicator, Chemical, Enzymatic, Sterilization Process, 1).
Next steps
- See all 6 True Indicating, LLC clearances with predicates and recalls
- Run predicate analysis for product code JOJ, True Indicating, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.