Cleared Special

K132841 - ZYNO MEDICAL ADMINISTRATION SET

K132841 is an FDA 510(k) clearance for ZYNO MEDICAL ADMINISTRATION SET, manufactured by Zyno Medical, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 135-day FDA review.

K132841 · Zyno Medical, LLC · General Hospital
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Jan 2014
Decision
135d
Days
Class 2
Risk

K132841 is an FDA 510(k) clearance for the ZYNO MEDICAL ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Zyno Medical, LLC (Natick, US). The FDA issued a Cleared decision on January 23, 2014 after a review of 135 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 - K132841

510(k) Number K132841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2013
Decision Date January 23, 2014
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 572
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