Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Transamerican Technologies Intl. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971677 | ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR | Transamerican Technologies Intl. | 1997-08-20 | 105 | 0 |
| K963193 | ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 | Transamerican Technologies Intl. | 1996-11-13 | 90 | 0 |
| K934398 | ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE | Transamerican Technologies Intl. | 1994-02-14 | 159 | 0 |
| K864378 | CO2 LASER MICROMANIPULATOR | Transamerican Technologies Intl. | 1987-03-05 | 120 | 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