Cleared Traditional

K071545 - Z-800 VOLUMETRIC INFUSION PUMP

K071545 is an FDA 510(k) clearance for Z-800 VOLUMETRIC INFUSION PUMP, manufactured by Zyno Medical, LLC. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K071545 · Zyno Medical, LLC · General Hospital
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Oct 2007
Decision
147d
Days
Class 2
Risk

K071545 is an FDA 510(k) clearance for the Z-800 VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Zyno Medical, LLC (Waltham, US). The FDA issued a Cleared decision on October 31, 2007 after a review of 147 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Zyno Medical, LLC devices

FDA 510(k) Submission Details - K071545

510(k) Number K071545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2007
Decision Date October 31, 2007
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 481
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K071545.
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K070125 · Baxter Healthcare Corp · Apr 2007
STRYKER AUTO IRRIGATION SYSTEM
K061108 · Stryker · Feb 2007