Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
La Jolla Technology, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
145 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870160 | DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS | La Jolla Technology, Inc. | 1987-04-01 | 78 | 0 |
| K864956 | DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. | La Jolla Technology, Inc. | 1987-03-09 | 81 | 0 |
| K854204 | DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS | La Jolla Technology, Inc. | 1986-01-10 | 86 | 0 |
| K832888 | ECG INTERFERENCE FILTER TF-03 | La Jolla Technology, Inc. | 1984-01-18 | 145 | 0 |
| K830932 | NYNEX II | La Jolla Technology, Inc. | 1983-04-18 | 26 | 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