Cleared Traditional

K123267 - SURFFLASH(R) PLUS SAFETY I.V. CATHETER (FDA 510(k) Clearance)

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

K123267 · Kofu Factory of Terumo Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
14d
Days
Class 2
Risk

K123267 is an FDA 510(k) clearance for the SURFFLASH(R) PLUS 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 November 2, 2012 after a review of 14 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. 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 Kofu Factory of Terumo Corp. devices

Submission Details

510(k) Number K123267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2012
Decision Date November 02, 2012
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K123267.
Introcan Safety® Deep Access XL IV Catheter
K253235 · B.Braun Medical, Inc. · May 2026
BD Insyte™ IV Catheter
K252137 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2026
Polywin Safety (14G x 51mm
K252513 · Poly Medicure Limited · Apr 2026
SURFLO Hybria Closed System Safety IV Catheter
K252398 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 2025
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