Cleared Special

K133867 - SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)

K133867 is an FDA 510(k) clearance for SURFLO WINGED INFUSION SET WITH NEEDLE ..., 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 47-day FDA review.

K133867 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
47d
Days
Class 2
Risk

K133867 is an FDA 510(k) clearance for the SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD). 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 February 5, 2014 after a review of 47 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.

FDA 510(k) Submission Details - K133867

510(k) Number K133867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2013
Decision Date February 05, 2014
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 K133867.
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K132142 · Unomedical A/S · Oct 2013
K133867 · SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
Download PDF FDA Summary Terumo Europe N.V.