Cleared Traditional

K150731 - Medline Epidural Catheter

K150731 is an FDA 510(k) clearance for Medline Epidural Catheter, manufactured by Medline Industries, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K150731 · Medline Industries, Inc. · Anesthesiology device
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Mar 2016
Decision
353d
Days
Class 2
Risk

K150731 is an FDA 510(k) clearance for the Medline Epidural Catheter. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 7, 2016 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K150731

510(k) Number K150731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2015
Decision Date March 07, 2016
Days to Decision 353 days
Submission Type Traditional
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
213d slower than avg
Panel avg: 140d · This submission: 353d
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 41
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K150731.
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PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
K090884 · B.Braun Medical, Inc. · Jun 2009
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K080675 · PAJUNK GmbH Medizintechnologie · Jun 2008
BUSSE EPIDURAL CATHETER
K070465 · Busse Hospital Disposables, Inc. · Jul 2007