# Shenzhen Homed Medical Device Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 4 (2017–2025): 4 510(k) clearances
- Product codes: CAF (3), CAW (1)
- 510(k) review time since 2016: median 343 days, against 177 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (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
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)
- Sunrise Medical, Inc.: 1 (https://510kreport.com/company/sunrise-medical)
- Inogen, Inc.: 1 (https://510kreport.com/company/inogen)
- Besmed Health Business Corp: 1 (https://510kreport.com/company/besmed-health-business)

## Recent decisions
- K252616: Portable oxygen concentrator (JLO-190P) (Dec 22, 2025)
- K212395: Nebulizer (Mar 25, 2022)
- K170886: HOMED Mesh Nebulizer (Jun 21, 2018)
- K161586: The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) (Sep 6, 2017)

Source page: https://510kreport.com/company/shenzhen-homed-medical-device