Cleared Special

K100946 - INTRAVSCULAR ADMINISTRATION SET

K100946 is an FDA 510(k) clearance for INTRAVSCULAR ADMINISTRATION SET, manufactured by Terumo Europe N.V.. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 118-day FDA review.

K100946 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
118d
Days
Class 2
Risk

K100946 is an FDA 510(k) clearance for the INTRAVSCULAR ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on August 2, 2010 after a review of 118 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 - K100946

510(k) Number K100946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2010
Decision Date August 02, 2010
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
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 1171
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K100946.
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K100434 · Icu Medical, Inc. · Jul 2010
K100946 · INTRAVSCULAR ADMINISTRATION SET
Download PDF FDA Summary Terumo Europe N.V.