Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
J-Tech, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
261 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954737 | SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE | J-Tech, Inc. | 1996-07-03 | 261 | 0 |
| K954647 | INCLINOMETER | J-Tech, Inc. | 1995-10-30 | 20 | 0 |
| K945630 | LARGE MUSCLE STRENGTH GAUGE | J-Tech, Inc. | 1995-05-10 | 175 | 0 |
| K913587 | JTECH 50 SERIES CUTTING LOOP | J-Tech, Inc. | 1991-10-23 | 72 | 0 |
| K912526 | GS-220 HAND IMPAIRMENT EVALUATION SYSTEM | J-Tech, Inc. | 1991-09-05 | 90 | 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