Trionix Research Laboratory, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Trionix Research Laboratory, Inc.” (first 1988, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time under this name: 85 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 16 | 16 |
Review panels
- Radiology (16)
Most recent Trionix Research Laboratory, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964438 | 511 KEV COLLIMATOR | KPS | 1997-05-29 | 205 |
| K962481 | QUASAR RECOVERY IMAGING PACKAGE | KPS | 1996-11-27 | 154 |
| K964268 | TRIAD 88 NUCLEAR IMAGING SYSTEM | KPS | 1996-11-12 | 19 |
| K964267 | MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM | KPS | 1996-11-12 | 19 |
| K964266 | BIAD NUCLEAR IMAGING SYSTEM | KPS | 1996-11-12 | 19 |
| K964265 | CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM | KPS | 1996-11-12 | 19 |
| K961597 | GATED MIBI 3-D EJECTION FRACTION PROCESSING | KPS | 1996-09-04 | 133 |
| K923345 | BIAD NEW DETECTOR OPTION | KPS | 1992-09-10 | 78 |
| K923151 | CARDIAC TRIAD NEW DETECTOR OPTION | KPS | 1992-09-10 | 78 |
| K923044 | MONAD NUCLEAR IMAGING SYSTEM | KPS | 1992-08-27 | 64 |
6 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-08-01.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Trionix Research Laboratory, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Trionix Research Laboratory, Inc.” (first 1988, latest 1997), across 1 product code 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 Trionix Research Laboratory, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trionix Research Laboratory, Inc. is 85 days.
Which FDA product codes appear under Trionix Research Laboratory, Inc.?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 16).
Next steps
- See all 16 Trionix Research Laboratory, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPS, Trionix Research Laboratory, Inc.'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.