# Zyno Medical, LLC

- Location (FDA's records): Natick, MA
- FDA decisions: 7 (2007–2016): 7 510(k) clearances
- Product codes: FRN (5), FPA (2)
- Predicates its devices cite: 16 (6 its own); citations of its devices by later devices: 9 (6 its own)
- Recalls linked to its devices: 21 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smiths Medical Asd, Inc.: 2 (https://510kreport.com/company/smiths-medical-asd)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Amsino Intl., Inc.: 1 (https://510kreport.com/company/amsino-intl)
- Health Line International Corporation: 1 (https://510kreport.com/company/health-line-international)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Sigma Intl. General Medical Apparatus, Inc.: 1 (https://510kreport.com/company/sigma-intl-general-medical-apparatus)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Sims Deltec, Inc.: 1 (https://510kreport.com/company/sims-deltec)

## Firms that cite its devices most
- Deka Research and Development: 1 (https://510kreport.com/company/deka-research-and-development)
- U&U Medical Technology Co, Ltd.: 1 (https://510kreport.com/company/u-u-medical-technology)
- Amsino International, Inc.: 1 (https://510kreport.com/company/amsino-international)

## Its most-cited devices
- K120685: Zyno Medical Administration Set (2012), cited by 6
- K071545: Z-800 Volumetric  Infusion Pump (2007), cited by 1
- K100705: Zyno Z-800 Infusion System Model Z-800 (2010), cited by 1
- K140783: Halo Ambulatory Infusion System (2014), cited by 1

## Recent decisions
- K153193: Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) (Aug 30, 2016)
- K140783: Halo Ambulatory Infusion System (Oct 17, 2014)
- K132841: Zyno Medical Administration Set (Jan 23, 2014)
- K130690: Z-800 Infusion System (Jun 12, 2013)
- K120685: Zyno Medical Administration Set (Sep 7, 2012)
- K100705: Zyno Z-800 Infusion System Model Z-800 (Jul 8, 2010)
- K071545: Z-800 Volumetric  Infusion Pump (Oct 31, 2007)

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