ClearanceBrief
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

CodeDeviceRecords
FRNPump, Infusion14
FPASet, Administration, Intravascular8
OPPPump, Infusion, Insulin Bolus1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 30, 2016K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion
Zyno Medical, LLC
FRN
Oct 17, 2014K140783HALO AMBULATORY INFUSION SYSTEM
Zyno Medical, LLC
FRN
Jan 23, 2014K132841ZYNO MEDICAL ADMINISTRATION SET
Zyno Medical, LLC
FPA
Jun 12, 2013K130690Z-800 INFUSION SYSTEM
Zyno Medical, LLC
FRN
Sep 7, 2012K120685ZYNO MEDICAL ADMINISTRATION SET
Zyno Medical, LLC
FPA
Jul 8, 2010K100705ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
Zyno Medical, LLC
FRN
Oct 31, 2007K071545Z-800 VOLUMETRIC INFUSION PUMP
Zyno Medical, LLC
FRN

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 6, 2025Zyno Medical LLC
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Open, Classified
FRNK100705
K130690
Jun 6, 2025Zyno Medical LLC
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Open, Classified
FRNK100705
K130690
Jun 6, 2025Zyno Medical LLC
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Open, Classified
FRNK100705
K130690
Jun 6, 2025Zyno Medical LLC
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Open, Classified
FRNK100705
K130690
Nov 22, 2024Zyno 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
FRNK100705
K130690
Nov 21, 2024Zyno 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
FRNK100705
K130690
Oct 9, 2024Zyno 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
FRNK100705
K130690
Jul 3, 2024Zyno Medical LLC
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Open, Classified
FRNK130690
Feb 23, 2024Zyno 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
FRNK130690
May 29, 2019Zyno 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
FPAK132841
May 29, 2019Zyno 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
FPAK132841
Sep 27, 2016Zyno 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
FPAK132841
Sep 27, 2016Zyno 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
FPAK132841
Sep 27, 2016Zyno 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
FPAK132841
Sep 27, 2016Zyno 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
FPAK132841
Mar 29, 2013Zyno Medical LLC
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Terminated
OPPK071545
K100705
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