# Sun Medical, Inc.

- Location (FDA's records): Arlington, TX
- FDA decisions: 6 (1985–2015): 6 510(k) clearances
- Names in FDA's records: Sun Medical, Inc. (4); Sun Medical Co., Ltd. (2)
- Product codes: EBI (2), FYD (1), HIF (1), GEX (1), HDY (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kulzer, Inc.: 1 (https://510kreport.com/company/kulzer)
- Yamahachi Dental Manufacturing Co.: 1 (https://510kreport.com/company/yamahachi-dental-manufacturing)

## Firms that cite its devices most
- Surgiquest, Inc.: 2 (https://510kreport.com/company/surgiquest)

## Its most-cited devices
- K911154: Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200 (1991), cited by 2

## Recent decisions
- K150511: Coating Material (May 27, 2015)
- K143265: Acrylic Block (Apr 14, 2015)
- K921963: Disposable, Filtered Insufflation Tubing, 92-900 (Sep 11, 1992)
- K911154: Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200 (Jul 26, 1991)
- K874948: Sun Medical Smoke Evacuator System (Feb 18, 1988)
- K845006: Sun Medical Laminaria Cervical Dilator (May 1, 1985)

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