Cleared Traditional

K040139 - ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER

K040139 is an FDA 510(k) clearance for ENDOBIONICS MICROSYRINGE (USYRINGE) INF..., manufactured by Endobionics, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K040139 · Endobionics, Inc. · Cardiovascular device
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Feb 2004
Decision
27d
Days
Class 2
Risk

K040139 is an FDA 510(k) clearance for the ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Endobionics, Inc. (San Leandro, US). The FDA issued a Cleared decision on February 18, 2004 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight 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 Endobionics, Inc. devices

FDA 510(k) Submission Details - K040139

510(k) Number K040139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2004
Decision Date February 18, 2004
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRA Catheter, Continuous Flush

All 143
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K040139.
HYPERTRANSIT INFUSION CATHETER
K043538 · Cordis Neurovascular, Inc. · Apr 2005
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
K042187 · Micro Therapeutics, Inc. · Sep 2004
PROGREAT
K033913 · Terumo Medical Corp. · Mar 2004
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
K034036 · Micro Therapeutics, Inc. · Feb 2004
ECHELON MICRO CATHETER, MODEL 105-5091
K031992 · Micro Therapeutics, Inc. · Aug 2003
ECHELON MICRO CATHETER, MODEL 105-5092-150
K030688 · Micro Therapeutics, Inc. · Mar 2003