Data / Medical devices / United States / Zyno Medical LLC.
Zyno Medical LLC.: FDA-registered device maker in Natick, MA, United States, 3 510(k) clearances
Zyno Medical LLC. is registered with the FDA (registration 3006575795) in Natick, MA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 23, 2014. 9 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006575795
- Address
- 177 Pine St, Natick, MA, United States, 01760
- Owner or operator
- Zyno Medical LLC. (10023155)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 19, 2013
- Registered through
- 2026
- Brand names listed
- Z-800 Series Volumetric Infusion System, Zyno Administration Sets, Zyno Medical Administration Sets
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Infusion | FRN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 23, 2014 | K132841 | ZYNO MEDICAL ADMINISTRATION SET | FPA | Substantially Equivalent | Zyno Medical, LLC | accessdata.fda.gov |
| June 12, 2013 | K130690 | Z-800 INFUSION SYSTEM | FRN | Substantially Equivalent | Zyno Medical, LLC | accessdata.fda.gov |
| September 7, 2012 | K120685 | ZYNO MEDICAL ADMINISTRATION SET | FPA | Substantially Equivalent | Zyno Medical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 7, 2025 | 96796 | Class I | Ongoing | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. | Unreleased software versions were installed on distributed devices without verification or validation. | accessdata.fda.gov |
| October 18, 2024 | 95601 | Class II | Ongoing | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the di | Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. | accessdata.fda.gov |
| September 30, 2024 | 95635 | Class III | Ongoing | Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient un | For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024. | accessdata.fda.gov |
| September 13, 2024 | 95382 | Class I | Ongoing | Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z | There is a defect in the air-in-line software algorithm. | accessdata.fda.gov |
| June 4, 2024 | 94768 | Class II | Ongoing | Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps | Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power. | accessdata.fda.gov |
| December 20, 2023 | 93857 | Class II | Ongoing | Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified healt | When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death | accessdata.fda.gov |
| May 29, 2019 | 83026 | Class II | Terminated | Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072 | Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume | accessdata.fda.gov |
| July 29, 2016 | 74892 | Class II | Terminated | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyno Medical Administration S | Administration Set potential filter leaking | accessdata.fda.gov |
| June 13, 2011 | 64448 | Class II | Terminated | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. | Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump | accessdata.fda.gov |
Compare with other makers
Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.