Tri-Tech, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Tri-Tech, Inc.” (first 1981, latest 1997), across 6 product codes in 6 review panels. Median 510(k) review time under this name: 168 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 |
|---|---|---|---|
| ISD | Exerciser, Measuring | 4 | 4 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| DOF | Lead, Atomic Absorption | 1 | 1 |
| FMH | Container, Specimen, Sterile | 1 | 1 |
| JXA | Kit, Screening, Urine | 1 | 1 |
Review panels
- Physical Medicine (4)
- Clinical Chemistry (3)
- Anesthesiology (1)
- General Hospital (1)
- Microbiology (1)
- Clinical Toxicology (1)
Most recent Tri-Tech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971111 | TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER | JKA | 1997-06-16 | 82 |
| K952246 | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT | JXA | 1995-06-20 | 39 |
| K922343 | TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT | JKA | 1994-02-17 | 639 |
| K922342 | TRI-TECH INC. CUSTOM BLOOD ALCOHOL | JKA | 1993-08-27 | 465 |
| K912140 | STAIRMASTER MODEL 6000 ERGOMETER | ISD | 1991-12-17 | 217 |
| K912058 | GAUNTLET STAIR CLIMBER | ISD | 1991-10-24 | 168 |
| K912057 | 4000 PT EXERCISE SYSTEM | ISD | 1991-10-24 | 168 |
| K912056 | GRAVITRON UPPER BODY SYSTEM EXERCISER | ISD | 1991-10-24 | 168 |
| K900983 | TRI-TECH URINE SPECIMEN KIT | FMH | 1990-09-17 | 199 |
| K843839 | STAT/PB REAGENT | DOF | 1985-01-03 | 94 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tri-Tech, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tri-Tech, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Tri-Tech, Inc.” (first 1981, latest 1997), across 6 product codes in 6 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-Tech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tri-Tech, Inc. is 168 days.
Which FDA product codes appear under Tri-Tech, Inc.?
The most frequent FDA product codes under this applicant name are ISD (Exerciser, Measuring, 4); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 3); BZD (Ventilator, Non-Continuous (Respirator), 1).
Next steps
- See all 11 Tri-Tech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ISD, Tri-Tech, 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.