Trek Diagnostic Systems, Inc.: FDA filings under this applicant name
FDA lists 68 510(k) clearances under the applicant name “Trek Diagnostic Systems, Inc.” (first 1998, latest 2014), plus 1 PMA decision, across 9 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 | 1 | 127 |
| 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 51 | 51 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 4 | 4 |
| NGZ | Susceptibility Test Plate, Antifungal | 4 | 4 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 3 | 3 |
| LIE | Reagent/Device, Inoculum Calibration | 2 | 2 |
| MJA | Susceptibility Test Powders, Antimycobacterial | 2 | 2 |
| JTW | System, Transport, Aerobic | 1 | 1 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 1 | 0 |
| MDB | System, Blood Culturing | 1 | 1 |
Review panels
- Microbiology (69)
Most recent Trek Diagnostic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | NGZ | 2014-01-31 | 127 |
| K112276 | VIZION | JWY | 2011-11-16 | 99 |
| K111615 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES | JWY | 2011-11-08 | 151 |
| K110583 | SENSITITRE OPTIREAD | LRG | 2011-09-22 | 205 |
| K103532 | AUTOREADER 2 | LRG | 2011-08-26 | 268 |
| K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... | JWY | 2011-08-18 | 87 |
| K103456 | THE SENSITITRE AIM | LIE | 2011-06-22 | 210 |
| K110331 | SENSITITRE AIM (TM) | LIE | 2011-04-27 | 83 |
| K093741 | SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES | JWY | 2010-02-25 | 83 |
| K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES | JWY | 2010-02-17 | 63 |
58 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N50531 | PMA | SENSITITRE | 1979-05-04 |
Recalls
5 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2012-07-23.
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.
- Trek Medical Products, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trek Diagnostic Systems, Inc.?
FDA lists 68 510(k) clearances under the applicant name “Trek Diagnostic Systems, Inc.” (first 1998, latest 2014), plus 1 PMA decision, across 9 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 Trek Diagnostic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trek Diagnostic Systems, Inc. is 63 days.
Which FDA product codes appear under Trek Diagnostic Systems, Inc.?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 51); LTT (Panels, Test, Susceptibility, Antimicrobial, 4); NGZ (Susceptibility Test Plate, Antifungal, 4).
Next steps
- See all 68 Trek Diagnostic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Trek Diagnostic Systems, 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.