# Hsiner Co., Ltd.

- Location (FDA's records): Temecula, CA
- FDA decisions: 9 (2005–2026): 9 510(k) clearances
- Names in FDA's records: Hsiner Co., Ltd. (7); Hsiner (1); Hsiner Company (1)
- Product codes: CAF (3), CBK (2), BZD (2), CAH (1), BTM (1)
- Predicates its devices cite: 25 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Respironics, Inc.: 6 (https://510kreport.com/company/respironics)
- Hudson Respiratory Care, Inc.: 3 (https://510kreport.com/company/hudson-respiratory-care)
- Resmed, Ltd.: 2 (https://510kreport.com/company/resmed)
- Gibeck, Inc.: 1 (https://510kreport.com/company/gibeck)
- Headstar Medical Products Co., Ltd.: 1 (https://510kreport.com/company/headstar-medical-products)
- Ventlab Corp.: 1 (https://510kreport.com/company/ventlab)
- Ambu, Inc.: 1 (https://510kreport.com/company/ambu)
- Hudson Oxygen Therapy Sales Co.: 1 (https://510kreport.com/company/hudson-oxygen-therapy-sales)

## Firms that cite its devices most
- Galemed Corp.: 1 (https://510kreport.com/company/galemed)
- Besmed Health Business Corp: 1 (https://510kreport.com/company/besmed-health-business)
- Genadyne Biotechnologies, Inc.: 1 (https://510kreport.com/company/genadyne-biotechnologies)

## Its most-cited devices
- K052811: Hsiner Jet Nebulizer, Model HS-31100 (2005), cited by 3
- K063268: Cpap/Vpap Masks, Models 1225, 1205 and 1235 (2007), cited by 3
- K070948: Hsiner Nebulizer Bottle (2007), cited by 1
- K120920: Hsiner Cpap Silicone Nasal Mask Size XS/Petite  Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula (2012), cited by 1

## Recent decisions
- K251888: VPAP Pediatric Face Mask (Mar 12, 2026)
- K120920: Hsiner Cpap Silicone Nasal Mask Size XS/Petite  Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula (Jul 16, 2012)
- K102120: Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202 (Aug 12, 2011)
- K091185: 70530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral Filter (Jul 24, 2009)
- K082009: Hsiner Nebulizer Bottle, CPR Masks and Face Shields (Aug 22, 2008)
- K070948: Hsiner Nebulizer Bottle (Apr 25, 2007)
- K063268: Cpap/Vpap Masks, Models 1225, 1205 and 1235 (Feb 23, 2007)
- K053466: Hsiner Resuscitator (Mar 22, 2006)

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