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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Kema Quality B.V.
J.A. VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KRA Catheter, Continuous Flush

All 174
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K040139.
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K033569 · Flowmedica, Inc. · Jan 2004
K040139 · ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER
Download PDF FDA Summary Endobionics, Inc.