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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 932
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K132841.
CAIR DRIVE, NEUTRACLEAR
K133073 · Cair Lgl · Mar 2014
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
K133894 · Terumo Europe N.V. · Mar 2014
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K133867 · Terumo Europe N.V. · Feb 2014
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
K132880 · Medical Components, Inc. · Jan 2014
NERIA SOFT 90 INFUSION SET
K132142 · Unomedical A/S · Oct 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
K132734 · Baxter Healthcare Corp · Oct 2013