WELL LEAD MEDICAL CO. LTD
FDA Regulatory Profile
WELL LEAD MEDICAL CO. LTD appears in FDA public data with 1 recall, 17 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3172-2026, Class II) was initiated on July 31, 2026. Its most recent 510(k) clearance was granted on March 5, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 17
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3172-2026 | Class II | SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25 | July 31, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter | March 5, 2025 |
| K220722 | PVC Hydrophilic Urethral Catheter | May 22, 2023 |
| K220036 | Wellead Ureteral Catheter | December 16, 2022 |
| K211543 | Wei Nasal Jet Tube | July 21, 2022 |
| K211814 | Wellead Endoscopic Seal | January 14, 2022 |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | April 8, 2021 |
| K203119 | ClearPetra Suction-Evacuation Sheath | December 9, 2020 |
| K182739 | Endotracheal Tube with Evacuation Lumen | December 11, 2019 |
| K162340 | Stomach Tube | October 11, 2017 |
| K160801 | Well Lead Extraction Bag | November 29, 2016 |
| K161110 | ClearPetra Suction-Evacuation Sheath | October 12, 2016 |
| K151084 | Well Lead Ureteral Access Sheath | January 7, 2016 |
| K140667 | WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER | December 15, 2014 |
| K142563 | Well Lead PVC Urethral Catheter | October 28, 2014 |
| K133615 | WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER | February 24, 2014 |
| K110269 | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL | August 26, 2011 |
| K091516 | WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR | October 16, 2009 |