Cleared Traditional

K153297 - Perifix and Contiplex Catheter (FDA 510(k) Clearance)

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

K153297 · B.Braun Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
273d
Days
Class 2
Risk

K153297 is an FDA 510(k) clearance for the Perifix and Contiplex Catheter. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on August 12, 2016 after a review of 273 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 B.Braun Medical, Inc. devices

Submission Details

510(k) Number K153297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2015
Decision Date August 12, 2016
Days to Decision 273 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
134d slower than avg
Panel avg: 139d · This submission: 273d
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.