Cleared Traditional

SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT (K081404) - FDA 510(k) Clearance

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

K081404 · Spinal Integration, LLC · Anesthesiology device
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Oct 2008
Decision
155d
Days
Class 2
Risk

K081404 is an FDA 510(k) clearance for the SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Spinal Integration, LLC (Orlando, US). The FDA issued a Cleared decision on October 21, 2008 after a review of 155 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Spinal Integration, LLC devices

Submission Details

510(k) Number K081404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date October 21, 2008
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 140d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 23
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K081404.
Perifix and Contiplex Catheter
K153297 · B.Braun Medical, Inc. · Aug 2016
Medline Epidural Catheter
K150731 · Medline Industries, Inc. · Mar 2016
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
K090884 · B.Braun Medical, Inc. · Jun 2009
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