Tronomed, Inc.: FDA clearances and approvals
Tronomed, Inc. has 12 FDA 510(k) clearances (first 1977, latest 1996), across 4 product codes in 3 review panels. Median 510(k) review time: 84 days.
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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | 5 | 5 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 4 | 4 |
| BZQ | Monitor, Breathing Frequency | 2 | 2 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
Review panels
- General Hospital (6)
- Cardiovascular (4)
- Anesthesiology (2)
Most recent Tronomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952659 | TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM | DSA | 1996-01-11 | 213 |
| K853303 | LIFELINC LEADWIRE | BZQ | 1985-09-18 | 43 |
| K853452 | LIFE LINC PATIENT CABLE | BZQ | 1985-09-10 | 25 |
| K841092 | HIGH PRESSURE FLEX. CONNECTING TUBING | DXT | 1985-07-24 | 498 |
| K792128 | STERILE EXTENSION TUBES INDIV. PKG. | FMG | 1980-01-16 | 84 |
| K792127 | PLAS. STCK. W/EXTENSION TUBE/STERILE | FMG | 1980-01-16 | 84 |
| K792126 | 3&4 WAY PLASTIC STERILE STPCKS. PKG. | FMG | 1980-01-16 | 84 |
| K792125 | 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE | FMG | 1980-01-16 | 84 |
| K792124 | TANDEM ASSEMBLED 3&4 WAY STOPCOCKS | FMG | 1980-01-16 | 84 |
| K771645 | ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE | DSA | 1977-10-18 | 50 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tronomed, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tronomed, Inc. have?
Tronomed, Inc. has 12 FDA 510(k) clearances (first 1977, latest 1996), across 4 product codes in 3 review panels.
How long does FDA take to clear Tronomed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tronomed, Inc.'s cleared 510(k)s is 84 days.
What devices does Tronomed, Inc. make?
Its most frequent FDA product codes are FMG (Stopcock, I.V. Set, 5); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 4); BZQ (Monitor, Breathing Frequency, 2).
Has Tronomed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tronomed, Inc. Related entities may recall under other names.
Next steps
- See all 12 Tronomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMG, Tronomed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.