Cleared Traditional

K134019 - MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO

K134019 is an FDA 510(k) clearance for MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE W..., manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K134019 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
255d
Days
Class 2
Risk

K134019 is an FDA 510(k) clearance for the MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROT.... Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on September 11, 2014 after a review of 255 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K134019

510(k) Number K134019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2013
Decision Date September 11, 2014
Days to Decision 255 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 131d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIE Device Classification - Class 2, Special Controls

Product Code FIE Needle, Fistula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIE Needle, Fistula

All 71
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K134019.
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K142564 · JMS North America Corporation · Dec 2014
APLAN A.V. FISTULA NEEDLE SET
K112734 · Aplan Well Enterprise Co., Ltd. · Apr 2012
JMS APHERESIS NEEDLE SET WINGEATER(R) V2
K112178 · JMS North America Corporation · Oct 2011
WINGEATER V2
K111948 · JMS North America Corporation · Oct 2011