510(k) Report

FDA applicant

Zyno Medical, LLC

Natick, MA7 decisions2007–201621 recalls

FDA records 7 decisions for Zyno Medical, LLC (Natick, MA) from 2007 to 2016: 7 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and FPA (Set, Administration, Intravascular). Its devices cite 16 predicates, 6 of them its own earlier devices. 21 recalls are linked to its devices, 8 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Zyno Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 12010: 12012: 12013: 12014: 22016: 1
2007high 2 (2014) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

4in 2025

2011: 12016: 42019: 32021: 12023: 12024: 7, 4 Class I2025: 4, 4 Class I
2007high 7 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Zyno Medical, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRNPump, Infusion5decisions
  • FPASet, Administration, Intravascular2decisions

Whose devices does it build on?

Its devices cite 16 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K120685Zyno Medical Administration SetZyno Medical, LLC · 20126cite it
  • K071545Z-800 Volumetric Infusion PumpZyno Medical, LLC · 20071cites it
  • K100705Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC · 20101cites it
  • K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 20141cites it

What has FDA decided for it lately?

  • K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA…Zyno Medical, LLC · 20163 Class I recalls
  • K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 20142 Class I recalls
  • K132841Zyno Medical Administration SetZyno Medical, LLC · 20146 recalls
  • K130690Z-800 Infusion SystemZyno Medical, LLC · 20135 Class I recalls
  • K120685Zyno Medical Administration SetZyno Medical, LLC · 2012
  • K100705Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC · 20105 Class I recalls
  • K071545Z-800 Volumetric Infusion PumpZyno Medical, LLC · 20071 recall

All 7 as Zyno Medical, LLC →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K100705Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids…May 7, 2025Class I
  • K130690Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids…May 7, 2025Class I
  • K130690Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids…May 7, 2025Class I
  • K130690Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids…May 7, 2025Class I
  • K130690Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800…Oct 18, 2024Class II
  • K130690Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF.…Sep 30, 2024Class III