Cleared Abbreviated

K120685 - ZYNO MEDICAL ADMINISTRATION SET

K120685 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 Abbreviated 510(k) pathway after a 185-day FDA review.

K120685 · Zyno Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
185d
Days
Class 2
Risk

K120685 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 September 7, 2012 after a review of 185 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Zyno Medical, LLC devices

FDA 510(k) Submission Details - K120685

510(k) Number K120685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2012
Decision Date September 07, 2012
Days to Decision 185 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 129d · This submission: 185d
Pathway characteristics
Standards-based clearance path.

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
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K120685.
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INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
K121634 · Baxter Healthcare Corporation · Jun 2012
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
K121032 · Hospira, Inc. · Jun 2012