Cleared Special

K043456 - MODIFICATION TO SOAKER CATHETER

K043456 is an FDA 510(k) clearance for MODIFICATION TO SOAKER CATHETER, manufactured by I-Flow Corp.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Special 510(k) pathway after a 27-day FDA review.

K043456 · I-Flow Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
27d
Days
Class 2
Risk

K043456 is an FDA 510(k) clearance for the MODIFICATION TO SOAKER CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by I-Flow Corp. (Lake Forest, US). The FDA issued a Cleared decision on January 11, 2005 after a review of 27 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 I-Flow Corp. devices

FDA 510(k) Submission Details - K043456

510(k) Number K043456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2004
Decision Date January 11, 2005
Days to Decision 27 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
113d faster than avg
Panel avg: 140d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

BSO Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K043456.
PORTEX EPIDURAL CATHETER
K062005 · Smiths Medical Asd, Inc. · Oct 2006
ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
K051401 · I-Flow Corp. · Nov 2005
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
K051524 · Smiths Medical Asd, Inc. · Jul 2005
PERIFIX CATHETER AND CONTIPLEX CATHETER
K042488 · B.Braun Medical, Inc. · Sep 2004
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K032390 · Ebi, L.P. · Aug 2003
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K023233 · Ebi, L.P. · Dec 2002