Cleared Traditional

K070362 - SURFLO WINGED INFUSION SET

K070362 is the FDA 510(k) clearance for SURFLO WINGED INFUSION SET by Terumo Europe N.V.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K070362 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
89d
Days
Class 2
Risk

K070362 is an FDA 510(k) clearance for the SURFLO WINGED INFUSION 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 May 7, 2007 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo Europe N.V. devices

Submission Details

510(k) Number K070362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2007
Decision Date May 07, 2007
Days to Decision 89 days
Submission Type Traditional
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
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 486
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K070362.
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED
K072576 · Baxter Healthcare Corp · Nov 2007
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K072894 · Terumo Europe N.V. · Nov 2007
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
K070547 · Terumo Europe N.V. · May 2007
SPIROS
K070532 · Icu Medical, Inc. · Mar 2007
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
K060074 · Baxter Healthcare Corp · Mar 2006
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K053106 · Icu Medical, Inc. · Jan 2006