Cleared Special

K141138 - SURFLASH SAFETY I.V. CATHETER (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K141138 · Kofu Factory of Terumo Corp. · General Hospital
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May 2014
Decision
28d
Days
Class 2
Risk

K141138 is an FDA 510(k) clearance for the SURFLASH SAFETY I.V. CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Kofu Factory of Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on May 30, 2014 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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.

View all Kofu Factory of Terumo Corp. devices

Submission Details

510(k) Number K141138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2014
Decision Date May 30, 2014
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 503
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K141138.
Introcan Safety® Deep Access XL IV Catheter
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Polywin Safety (14G x 51mm
K252513 · Poly Medicure Limited · Apr 2026
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Polyshield Safety IV Catheters
K252677 · Poly Medicure Limited · Nov 2025
BD Saf-T-Intima™ Subcutaneous Catheter System
K251422 · Becton Dickinson Infusion Therapy Systems, Inc. · Oct 2025