Cleared Traditional

K231242 - Perifix FX Catheter

Also marketed or referenced as:
Contiplex FX Catheter

K231242 is an FDA 510(k) clearance for Perifix FX Catheter, manufactured by B.Braun Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K231242 · B.Braun Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Sep 2023
Decision
137d
Days
Class 2
Risk

K231242 is an FDA 510(k) clearance for the Perifix FX Catheter. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 15, 2023 after a review of 137 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K231242

510(k) Number K231242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2023
Decision Date September 15, 2023
Days to Decision 137 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
3d faster than avg
Panel avg: 140d · This submission: 137d
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 61
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