# Well Lead Medical Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 17 (2009–2025): 17 510(k) clearances
- Product codes: EZL (3), FED (3), BTR (3), EZD (3), KNT (1), GBM (1), KOD (1), GCJ (1), ODC (1)
- 510(k) review time since 2016: median 256 days, against 126 for FDA's reviews in the same codes and years (1 of 8 faster)
- Predicates its devices cite: 28 (6 its own); citations of its devices by later devices: 14 (6 its own)
- Recalls linked to its devices: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Well Lead Medical Instruments: 2 (https://510kreport.com/company/well-lead-medical-instruments)
- Schoelly Fiberoptic GmbH: 2 (https://510kreport.com/company/schoelly-fiberoptic)
- Coloplast Corp.: 2 (https://510kreport.com/company/coloplast)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Fortune Medical Instrument Corp.: 1 (https://510kreport.com/company/fortune-medical-instrument)
- Alan Reid: 1 (https://510kreport.com/company/alan-reid)
- Respiratory Support Products, Inc.: 1 (https://510kreport.com/company/respiratory-support-products)
- Coloplast A/S: 1 (https://510kreport.com/company/coloplast-a-s)

## Firms that cite its devices most
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)
- Suzhou Beyo Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/suzhou-beyo-medical-technology)
- Salter Labs: 1 (https://510kreport.com/company/salter-labs)
- Youcare Technology Co.,Ltd. (Wuhan): 1 (https://510kreport.com/company/youcare-technology-co-wuhan)
- Kalera Medical, Inc.: 1 (https://510kreport.com/company/kalera-medical)
- Seplou (Zhuhai) Co., Ltd.: 1 (https://510kreport.com/company/seplou-zhuhai)
- Anhui Happiness Workshop Medical Instruments Co., Ltd.: 1 (https://510kreport.com/company/anhui-happiness-workshop-medical-instruments)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Its most-cited devices
- K161110: ClearPetra Suction-Evacuation Sheath (2016), cited by 6
- K151084: Well Lead Ureteral Access Sheath (2016), cited by 3
- K110269: Well Lead Endotracheal Tube with Evacuation Lumen-Oral (2011), cited by 2
- K133615: Well Lead PVC Hydrophilic Urethral Catheter (2014), cited by 2
- K091516: Well Lead Silicone Catheter with Temperature Sensor (2009), cited by 1

## Recent decisions
- K241734: Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact (Mar 5, 2025)
- K220722: PVC Hydrophilic Urethral Catheter (May 22, 2023)
- K220036: Wellead Ureteral Catheter (Dec 16, 2022)
- K211543: Wei Nasal Jet Tube (Jul 21, 2022)
- K211814: Wellead Endoscopic Seal (Jan 14, 2022)
- K202134: Well Lead All Silicone Foley Catheter with Temperature Sensor (Apr 8, 2021)
- K203119: ClearPetra Suction-Evacuation Sheath (Dec 9, 2020)
- K182739: Endotracheal Tube with Evacuation Lumen (Dec 11, 2019)

Source page: https://510kreport.com/company/well-lead-medical