Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Well Lead Medical Co., Ltd. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
251 daysmedian FDA review time
434 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wel | Well Lead Medical Co., Ltd. | 2025-03-05 | 261 | 0 |
| K220722 | PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 2023-05-22 | 434 | 0 |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | 2022-12-16 | 345 | 0 |
| K211543 | Wei Nasal Jet Tube | Well Lead Medical Co., Ltd. | 2022-07-21 | 428 | 0 |
| K211814 | Wellead Endoscopic Seal | Well Lead Medical Co., Ltd. | 2022-01-14 | 217 | 0 |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Senso | Well Lead Medical Co., Ltd. | 2021-04-08 | 251 | 0 |
| K203119 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2020-12-09 | 54 | 0 |
| K182739 | Endotracheal Tube with Evacuation Lumen | Well Lead Medical Co., Ltd. | 2019-12-11 | 439 | 0 |
| K162340 | Stomach Tube | Well Lead Medical Co., Ltd. | 2017-10-11 | 415 | 0 |
| K160801 | Well Lead Extraction Bag | Well Lead Medical Co., Ltd. | 2016-11-29 | 251 | 0 |
| K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016-10-12 | 175 | 0 |
| K151084 | Well Lead Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 2016-01-07 | 260 | 0 |
| K140667 | WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER | Well Lead Medical Co., Ltd. | 2014-12-15 | 272 | 0 |
| K142563 | Well Lead PVC Urethral Catheter | Well Lead Medical Co., Ltd. | 2014-10-28 | 47 | 0 |
| K133615 | WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER | Well Lead Medical Co., Ltd. | 2014-02-24 | 91 | 0 |
| K110269 | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL | Well Lead Medical Co., Ltd. | 2011-08-26 | 211 | 2 |
| K091516 | WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR | Well Lead Medical Co., Ltd. | 2009-10-16 | 147 | 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