Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lead-Lok, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
205 daysmedian FDA review time
585 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010431 | LEAD-LOK REUSABLE TENS/ NMES ELECTRODES | Lead-Lok, Inc. | 2001-09-06 | 205 | 0 |
| K911518 | BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM | Lead-Lok, Inc. | 1992-11-09 | 585 | 0 |
| K911529 | BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG | Lead-Lok, Inc. | 1992-11-09 | 585 | 0 |
| K903729 | GOLD GATORS | Lead-Lok, Inc. | 1990-09-14 | 29 | 0 |
| K895100 | ECHO GEL (RAINFOREST) | Lead-Lok, Inc. | 1989-11-03 | 80 | 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