Z-800 VOLUMETRIC INFUSION PUMP— 510(k) K071545

Name: FDA 510(k) clearance K071545
Creator: U.S. Food and Drug Administration
Published: 2007-10-31

Substantially Equivalent

Zyno Medical, LLC

FDA 510(k) clearance K071545 for Z-800 VOLUMETRIC INFUSION PUMP, Substantially Equivalent on 2007-10-31. Applicant: Zyno Medical, LLC. Device class: 2.

Clearance details

Applicant: Zyno Medical, LLC
Product code: Code FRN
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2007-06-06
Decision date: 2007-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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K132841 — ZYNO MEDICAL ADMINISTRATION SET2014-01-23
K130690 — Z-800 INFUSION SYSTEM2013-06-12
K120685 — ZYNO MEDICAL ADMINISTRATION SET2012-09-07

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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 →

Recalls naming K071545

K-number listed on FDA's recall record

Z-1024-2013 — Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.Class II·Terminated·Zyno Medical LLC·20110613

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071545.

Data sourced from openFDA. This site is unofficial and independent of the FDA.