Cleared Special

K032390 - MODIFICATION TO EBI TARGETCATH FLUORO-G...

K032390 is the FDA 510(k) clearance for MODIFICATION TO EBI TARGETCATH FLUORO-G... by Ebi, L.P.. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Special 510(k) pathway after a 25-day FDA review.

K032390 · Ebi, L.P. · Anesthesiology device
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Aug 2003
Decision
25d
Days
Class 2
Risk

K032390 is an FDA 510(k) clearance for the MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on August 29, 2003 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - the FDA anesthesiology and respiratory 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 Ebi, L.P. devices

Submission Details

510(k) Number K032390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date August 29, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 140d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BSO Catheter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSO Catheter, Conduction, Anesthetic

All 39
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K032390.
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
K051524 · Smiths Medical Asd, Inc. · Jul 2005
MODIFICATION TO SOAKER CATHETER
K043456 · I-Flow Corp. · Jan 2005
PERIFIX CATHETER AND CONTIPLEX CATHETER
K042488 · B.Braun Medical, Inc. · Sep 2004
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K023233 · Ebi, L.P. · Dec 2002
PERIFIX CATHETER CONNECTOR
K022019 · B.Braun Medical, Inc. · Aug 2002
SPIROL EPIDURAL CATHETER
K000886 · Abbott Laboratories · Oct 2000