Cleared Traditional

K102594 - IO-FLEX CATHETER

K102594 is an FDA 510(k) clearance for IO-FLEX CATHETER, manufactured by Baxano, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K102594 · Baxano, Inc. · Anesthesiology device
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Jan 2011
Decision
132d
Days
Class 2
Risk

K102594 is an FDA 510(k) clearance for the IO-FLEX CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Baxano, Inc. (San Jose, US). The FDA issued a Cleared decision on January 19, 2011 after a review of 132 days - within the typical 510(k) review window.

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 Baxano, Inc. devices

FDA 510(k) Submission Details - K102594

510(k) Number K102594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2010
Decision Date January 19, 2011
Days to Decision 132 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
8d faster than avg
Panel avg: 140d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 46
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K102594.
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BUSSE EPIDURAL CATHETER
K070465 · Busse Hospital Disposables, Inc. · Jul 2007