Cleared Traditional

K133280 - TERUMO SURFLO I.V. CATHETER

K133280 is an FDA 510(k) clearance for TERUMO SURFLO I.V. CATHETER, manufactured by Terumo (Philippines) Corporation. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K133280 · Terumo (Philippines) Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
230d
Days
Class 2
Risk

K133280 is an FDA 510(k) clearance for the TERUMO SURFLO I.V. CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Terumo (Philippines) Corporation (Elkton, US). The FDA issued a Cleared decision on June 12, 2014 after a review of 230 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Terumo (Philippines) Corporation devices

FDA 510(k) Submission Details - K133280

510(k) Number K133280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date June 12, 2014
Days to Decision 230 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
101d slower than avg
Panel avg: 129d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 414
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K133280.
NEXUS MIDLINE CT CATHETER
K140270 · Health Line International Corporation · Aug 2014
LEADERFLEX
K141026 · Vygon · Jul 2014
ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
K140504 · Vascular Pathways, Inc. · Jul 2014
SURFLASH SAFETY I.V. CATHETER
K141138 · Kofu Factory of Terumo Corp. · May 2014
SUPERCATH5
K140419 · Togo Medikit Co., Ltd. · May 2014
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
K140136 · Nipro Medical Corporation · Feb 2014