Well Lead Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Well Lead Medical Co., Ltd.” (first 2009, latest 2025), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 251 days. Since 2017 the median was 345 days, against 121 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 3 | 91 |
| 2015 | 0 | — |
| 2016 | 3 | 251 |
| 2017 | 1 | 415 |
| 2018 | 0 | — |
| 2019 | 1 | 439 |
| 2020 | 1 | 54 |
| 2021 | 1 | 251 |
| 2022 | 3 | 345 |
| 2023 | 1 | 434 |
| 2024 | 0 | — |
| 2025 | 1 | 261 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Well Lead Medical Co., Ltd. took a median 345 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 3 | 3 |
| EZD | Catheter, Straight | 3 | 3 |
| EZL | Catheter, Retention Type, Balloon | 3 | 3 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 3 | 3 |
| GBM | Catheter, Urethral | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
Most recent Well Lead Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | GBM | 2025-03-05 | 261 |
| K220722 | PVC Hydrophilic Urethral Catheter | EZD | 2023-05-22 | 434 |
| K220036 | Wellead Ureteral Catheter | KOD | 2022-12-16 | 345 |
| K211543 | Wei Nasal Jet Tube | BTR | 2022-07-21 | 428 |
| K211814 | Wellead Endoscopic Seal | ODC | 2022-01-14 | 217 |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | EZL | 2021-04-08 | 251 |
| K203119 | ClearPetra Suction-Evacuation Sheath | FED | 2020-12-09 | 54 |
| K182739 | Endotracheal Tube with Evacuation Lumen | BTR | 2019-12-11 | 439 |
| K162340 | Stomach Tube | KNT | 2017-10-11 | 415 |
| K160801 | Well Lead Extraction Bag | GCJ | 2016-11-29 | 251 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-07-31.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Well Brain International , Ltd. (4 510(k)s)
- Well Lead Medical Instruments (4 510(k)s)
- Well Success Biotech, Inc. (3 510(k)s)
- Well Arts Optical Factory , Ltd. (1 510(k)s)
- Well Being Ent. (1 510(k)s)
- Well Care (Wuhan) Medical Technology Co., Ltd. (1 510(k)s)
- Well Home Health Products Co. (1 510(k)s)
- Well Lead Instruments (1 510(k)s)
- Well Lead Medical (Hainan) Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Well Lead Medical Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Well Lead Medical Co., Ltd.” (first 2009, latest 2025), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Well Lead Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Well Lead Medical Co., Ltd. is 251 days. Since 2017: 345 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Well Lead Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 3); EZD (Catheter, Straight, 3); EZL (Catheter, Retention Type, Balloon, 3).
Next steps
- See all 17 Well Lead Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BTR, Well Lead Medical Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.