Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Well Lead Medical Instruments · 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) |
|---|---|---|---|---|---|
| K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | Well Lead Medical Instruments | 2008-10-08 | 13 | 0 |
| K073383 | WELL LEAD REINFORCED ENDOTRACHEAL TUBE | Well Lead Medical Instruments | 2008-07-10 | 220 | 0 |
| K042683 | WELL LEAD ENDOTRACHEAL TUBE | Well Lead Medical Instruments | 2005-02-18 | 142 | 0 |
| K042684 | WELL LEAD TRACHEOSTOMY TUBE | Well Lead Medical Instruments | 2005-02-17 | 141 | 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