Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tri-Tech, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
465 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971111 | TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER | Tri-Tech, Inc. | 1997-06-16 | 82 | 0 |
| K952246 | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT | Tri-Tech, Inc. | 1995-06-20 | 39 | 0 |
| K922343 | TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT | Tri-Tech, Inc. | 1994-02-17 | 639 | 0 |
| K922342 | TRI-TECH INC. CUSTOM BLOOD ALCOHOL | Tri-Tech, Inc. | 1993-08-27 | 465 | 0 |
| K912140 | STAIRMASTER MODEL 6000 ERGOMETER | Tri-Tech, Inc. | 1991-12-17 | 217 | 0 |
| K912056 | GRAVITRON UPPER BODY SYSTEM EXERCISER | Tri-Tech, Inc. | 1991-10-24 | 168 | 0 |
| K912058 | GAUNTLET STAIR CLIMBER | Tri-Tech, Inc. | 1991-10-24 | 168 | 0 |
| K912057 | 4000 PT EXERCISE SYSTEM | Tri-Tech, Inc. | 1991-10-24 | 168 | 0 |
| K900983 | TRI-TECH URINE SPECIMEN KIT | Tri-Tech, Inc. | 1990-09-17 | 199 | 0 |
| K843839 | STAT/PB REAGENT | Tri-Tech, Inc. | 1985-01-03 | 94 | 0 |
| K813075 | TRITEC DOC TM | Tri-Tech, Inc. | 1981-12-09 | 37 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda