Cleared Traditional

K771204 - SURFLO WINGED INFUSION SET

K771204 is an FDA 510(k) clearance for SURFLO WINGED INFUSION SET, manufactured by Terumo America, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K771204 · Terumo America, Inc. · General Hospital
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Jul 1977
Decision
9d
Days
Class 2
Risk

K771204 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 America, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1977 after a review of 9 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.

FDA 510(k) Submission Details - K771204

510(k) Number K771204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1977
Decision Date July 14, 1977
Days to Decision 9 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 129d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1177
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K771204.
FLU VEN 0150
K771362 · Venospital, Inc. · Aug 1977
FLUID HANDLING DEVICE W/INPUT TUBING
K771453 · Imed Corp. · Aug 1977
MALE LUER LOCK PLUG
K771339 · American Viggo · Aug 1977
SOLUSET FOR IV FAT EMULSION
K770743 · Abbott Laboratories · Jun 1977
FLU VEN 0160
K770863 · Venospital, Inc. · Jun 1977
BURETTE SET, 2C0132
K770763 · Travenol Laboratories, S.A. · Jun 1977
K771204 · SURFLO WINGED INFUSION SET
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