Cleared Special

K141306 - TEVADAPTOR (FDA 510(k) Clearance)

Also includes:
CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K141306 · Teva Medical Ltd., Migada Plant · General Hospital
Jun 2014
Decision
24d
Days
Class 2
Risk

K141306 is an FDA 510(k) clearance for the TEVADAPTOR. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Teva Medical Ltd., Migada Plant (Rome, IT). The FDA issued a Cleared decision on June 12, 2014 after a review of 24 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K141306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2014
Decision Date June 12, 2014
Days to Decision 24 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
145d faster than avg
Panel avg: 169d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 29
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