Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Therapeutic Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
143 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093705 | FUORECAM | Therapeutic Technologies, Inc. | 2010-04-23 | 143 | 0 |
| K900029 | SPECTRASTIM 2000 MUSCLE STIMULATOR | Therapeutic Technologies, Inc. | 1990-04-02 | 89 | 0 |
| K893964 | SPECTRASTIM TM 1000 | Therapeutic Technologies, Inc. | 1989-10-06 | 126 | 0 |
| K854277 | NEUROPATH 4000 | Therapeutic Technologies, Inc. | 1986-01-21 | 90 | 0 |
| K841112 | TTI REHABILATATION GYM SYS | Therapeutic Technologies, Inc. | 1984-04-04 | 20 | 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