Cleared Traditional

SURSHIELD SAFETY WINGED BLOOD COLLECTION SET (K031279) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031279 · Terumo Medical Products Hangzhou Co., Ltd. · General Hospital
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May 2003
Decision
38d
Days
Class 2
Risk

K031279 is an FDA 510(k) clearance for the SURSHIELD SAFETY WINGED BLOOD COLLECTION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Terumo Medical Products Hangzhou Co., Ltd. (Elkton, US). The FDA issued a Cleared decision on May 30, 2003 after a review of 38 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 Medical Products Hangzhou Co., Ltd. devices

Submission Details

510(k) Number K031279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2003
Decision Date May 30, 2003
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
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 238
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K031279.
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
K033576 · Abbott Laboratories · Dec 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350 · Becton, Dickinson & CO · Nov 2003
ULTRASITE VALVE
K031923 · B.Braun Medical, Inc. · Aug 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
K030002 · Abbott Laboratories · Jan 2003
SURECAN SAFETY HUBER NEEDLE INFUSION SETS
K021488 · B.Braun Medical, Inc. · Jul 2002
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · Terumo Medical Corp. · Oct 2001