Cleared Traditional

Medline Epidural Catheter (K150731) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 20
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K150731.
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
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Perifix and Contiplex Catheter
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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
PERIFIX CATHETER CONNECTOR
K022019 · B.Braun Medical, Inc. · Aug 2002