# Merchsource, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 3 (2025–2025): 3 510(k) clearances
- Product codes: OHS (2), IRP (1)
- 510(k) review time since 2016: median 105 days, against 89 for FDA's reviews in the same codes and years (0 of 3 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
- iSMART Developments, Ltd.: 1 (https://510kreport.com/company/ismart-developments)
- Dongguan Boyuan Intelligent Technology Co.,Ltd: 1 (https://510kreport.com/company/dongguan-boyuan-intelligent-technology)
- Rapid Reboot Recovery Products, LLC: 1 (https://510kreport.com/company/rapid-reboot-recovery-products)
- Foshan Hongfeng Co., Ltd.: 1 (https://510kreport.com/company/foshan-hongfeng)

## Recent decisions
- K251531: Air Compression Boots 1018195,1018196 (Oct 30, 2025)
- K252093: Light Therapy Mask (1019055) (Oct 16, 2025)
- K252096: Light Therapy Decollete Mask (1019135) (Oct 1, 2025)

Source page: https://510kreport.com/company/merchsource