# Well Lead Medical Instruments

- Location (FDA's records): Apollo Beach, FL
- FDA decisions: 4 (2005–2008): 4 510(k) clearances
- Product codes: BTR (2), BTO (1), EZL (1)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 20 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Rusch Intl.: 4 (https://510kreport.com/company/rusch-intl)
- Portex, Inc.: 1 (https://510kreport.com/company/portex)
- Rusch, Inc.: 1 (https://510kreport.com/company/rusch)
- Rochester Medical Corp.: 1 (https://510kreport.com/company/rochester-medical)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Hangzhou Bever Medical Devices Co., Ltd.: 2 (https://510kreport.com/company/hangzhou-bever-medical-devices)
- Well Lead Medical Co., Ltd.: 2 (https://510kreport.com/company/well-lead-medical)
- Suzhou Weikang Medical Apparatus Co., Ltd.: 2 (https://510kreport.com/company/suzhou-weikang-medical-apparatus)
- Tianjin Medis Medical Device Co., Ltd.: 2 (https://510kreport.com/company/tianjin-medis-medical-device)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)
- Amsino International, Inc.: 1 (https://510kreport.com/company/amsino-international)
- Well Lead Medical (Hainan) Co., Ltd.: 1 (https://510kreport.com/company/well-lead-medical-hainan)

## Its most-cited devices
- K042683: Well Lead Endotracheal Tube (2005), cited by 10
- K082815: Well Lead Silicone and Latex Foley Catheters (2008), cited by 6
- K073383: Well Lead Reinforced Endotracheal Tube (2008), cited by 3
- K042684: Well Lead Tracheostomy Tube (2005), cited by 1

## Recent decisions
- K082815: Well Lead Silicone and Latex Foley Catheters (Oct 8, 2008)
- K073383: Well Lead Reinforced Endotracheal Tube (Jul 10, 2008)
- K042683: Well Lead Endotracheal Tube (Feb 18, 2005)
- K042684: Well Lead Tracheostomy Tube (Feb 17, 2005)

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