Tri-Med, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Tri-Med, Inc.” (first 1977, latest 2004), across 15 product codes in 8 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| FPB | Filter, Infusion Line | 8 | 8 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 5 | 5 |
| BZQ | Monitor, Breathing Frequency | 2 | 2 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| JBP | Activated Whole Blood Clotting Time | 1 | 1 |
Plus 5 more product codes.
Review panels
- General Hospital (10)
- Anesthesiology (7)
- Gastroenterology and Urology (5)
- Orthopedic (3)
- Cardiovascular (1)
- Hematology (1)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Tri-Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040112 | TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE | HRS | 2004-03-12 | 52 |
| K030877 | TRIMED RADIAL BULLET | HRS | 2004-02-05 | 322 |
| K010545 | TBW | NDL | 2001-06-06 | 103 |
| K961863 | PARACENTESIS TRAYS | LRO | 1996-05-28 | 14 |
| K875224 | HUDSON CRANINAL BURRS | HBE | 1988-01-28 | 37 |
| K850747 | TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR | CCK | 1985-04-02 | 36 |
| K850746 | TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI | CCK | 1985-04-02 | 36 |
| K850745 | TRI-MED MODEL 112 MOISTURE TRAP | CCK | 1985-04-02 | 36 |
| K843681 | RESPIRATION & HEART RATE MONITOR 530 | BZQ | 1984-12-04 | 77 |
| K843285 | TRI-MED 610 CAPNOSTAT GAS ANALYZER | CCK | 1984-11-13 | 84 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tri-Med, Inc..
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.
- Tri-Med Specialties, Inc. (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tri-Med, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Tri-Med, Inc.” (first 1977, latest 2004), across 15 product codes in 8 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tri-Med, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tri-Med, Inc. is 45 days.
Which FDA product codes appear under Tri-Med, Inc.?
The most frequent FDA product codes under this applicant name are FPB (Filter, Infusion Line, 8); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 5); BZQ (Monitor, Breathing Frequency, 2).
Next steps
- See all 29 Tri-Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPB, Tri-Med, 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.