Company ยท US
Zyno Medical LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2016. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
16recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 30, 2016 | K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion Zyno Medical, LLC | FRN |
| Oct 17, 2014 | K140783 | HALO AMBULATORY INFUSION SYSTEM Zyno Medical, LLC | FRN |
| Jan 23, 2014 | K132841 | ZYNO MEDICAL ADMINISTRATION SET Zyno Medical, LLC | FPA |
| Jun 12, 2013 | K130690 | Z-800 INFUSION SYSTEM Zyno Medical, LLC | FRN |
| Sep 7, 2012 | K120685 | ZYNO MEDICAL ADMINISTRATION SET Zyno Medical, LLC | FPA |
| Jul 8, 2010 | K100705 | ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 Zyno Medical, LLC | FRN |
| Oct 31, 2007 | K071545 | Z-800 VOLUMETRIC INFUSION PUMP Zyno Medical, LLC | FRN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2025 | Zyno Medical LLC Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | K100705 K130690 |
| Jun 6, 2025 | Zyno Medical LLC Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | K100705 K130690 |
| Jun 6, 2025 | Zyno Medical LLC Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | K100705 K130690 |
| Jun 6, 2025 | Zyno Medical LLC Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | K100705 K130690 |
| Nov 22, 2024 | Zyno Medical LLC 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 prod Open, Classified |
FRN | K100705 K130690 |
| Nov 21, 2024 | Zyno Medical LLC 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 Open, Classified |
FRN | K100705 K130690 |
| Oct 9, 2024 | Zyno Medical LLC 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 Open, Classified |
FRN | K100705 K130690 |
| Jul 3, 2024 | Zyno Medical LLC Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps Open, Classified |
FRN | K130690 |
| Feb 23, 2024 | Zyno Medical LLC 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 o Open, Classified |
FRN | K130690 |
| May 29, 2019 | Zyno Medical LLC Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed
Product Code: B2-70072-F Terminated |
FPA | K132841 |
| May 29, 2019 | Zyno Medical LLC 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 Terminated |
FPA | K132841 |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set Sterile. Rx
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: B2-70072-F
Product Usage:
Zyno Medical Administration Set is a device used to adminis Terminated |
FPA | K132841 |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set, Sterile. RX
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: B2-70071-DF
Product Code: B2-70071-DF-120 (expanded recall)
Product Usage:
Zyno Med Terminated |
FPA | K132841 |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set, Sterile. Rx
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: A2-80072-F
Product Usage:
Zyno Medical Administration Set is a device used to admini Terminated |
FPA | K132841 |
| Sep 27, 2016 | Zyno Medical LLC 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 Med Terminated |
FPA | K132841 |
| Mar 29, 2013 | Zyno Medical LLC Z-800 Volumetric Infusion System.
For intravenous infusion of parenteral fluids, blood and blood products to a human patient. Terminated |
OPP | K071545 K100705 |