Cleared Traditional

K150800 - Valved Safety Centesis Catheter

K150800 is an FDA 510(k) clearance for Valved Safety Centesis Catheter, manufactured by B.Braun Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GCB cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K150800 · B.Braun Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Nov 2015
Decision
231d
Days
Class 1
Risk

K150800 is an FDA 510(k) clearance for the Valved Safety Centesis Catheter. Classified as Needle, Catheter (product code GCB), Class I - General Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 12, 2015 after a review of 231 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K150800

510(k) Number K150800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2015
Decision Date November 12, 2015
Days to Decision 231 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 115d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

GCB Device Classification - Class 1, General Controls

Product Code GCB Needle, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GCB Needle, Catheter

All 7
Devices cleared under the same product code (GCB) and FDA review panel - the closest regulatory comparables to K150800.
PARACENTESIS CATHETER DEVICE
K974146 · Allegiance Healthcare Corp. · Jan 1998
ADAIR/VERESS NEEDLE INTRODUCER SET
K930568 · Medical Dynamics, Inc. · Jul 1993
TURKEL PNEUMOTHORAX KIT
K923028 · Symbiosis Corp. · Aug 1992
ADAIR/VERESS NEEDLE INTRODUCER SET
K900374 · Medical Dynamics, Inc. · Apr 1990
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
K854327 · Concord Laboratories, Inc. · Nov 1985
MANAN EPIDURAL NEEDLE
K852428 · Manan Manufacturing Co., Inc. · Jun 1985