Cleared Special

K130690 - Z-800 INFUSION SYSTEM

K130690 is an FDA 510(k) clearance for Z-800 INFUSION SYSTEM, manufactured by Zyno Medical, LLC. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 90-day FDA review.

K130690 · Zyno Medical, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2013
Decision
90d
Days
Class 2
Risk

K130690 is an FDA 510(k) clearance for the Z-800 INFUSION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Zyno Medical, LLC (Natick, US). The FDA issued a Cleared decision on June 12, 2013 after a review of 90 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zyno Medical, LLC devices

FDA 510(k) Submission Details - K130690

510(k) Number K130690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2013
Decision Date June 12, 2013
Days to Decision 90 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

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
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