ZYNO MEDICAL ADMINISTRATION SET— 510(k) K132841

Clearance details

Applicant

Zyno Medical, LLC

Product code

Code FPA

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

2013-09-10

Decision date

2014-01-23

Decision

Substantially Equivalent

Clearance type

Special

Location

Natick, MA, US

• K254123 — Ecomed Disposable Administration Sets2026-09-11
• K261530 — iiSure Infusion Set2026-06-03
• K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)2026-05-04
• K251375 — PuraCath Firefly Needleless Connector IT (9005)2026-02-12
• K251257 — nSet+ Stabilization Set [6426733] +2 more2025-12-04

• K153193 — Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)2016-08-30
• K140783 — HALO AMBULATORY INFUSION SYSTEM2014-10-17
• K130690 — Z-800 INFUSION SYSTEM2013-06-12
• K120685 — ZYNO MEDICAL ADMINISTRATION SET2012-09-07
• K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-8002010-07-08

Death

95

Injury

14,421

Malfunction

125,815

Other

30

Total

140,361

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2058-2019 — 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:B2-70072Class II·Terminated·Zyno Medical LLC·20190529
• Z-2059-2019 — 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-FClass II·Terminated·Zyno Medical LLC·20190529
• Z-2893-2016 — 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 Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.Class II·Terminated·Zyno Medical LLC·20160729
• Z-2894-2016 — 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 administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.Class II·Terminated·Zyno Medical LLC·20160729
• Z-2895-2016 — 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 Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.Class II·Terminated·Zyno Medical LLC·20160729
• Z-2896-2016 — 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 administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.Class II·Terminated·Zyno Medical LLC·20160729

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132841.