Cleared Traditional

K141464 - NOVAGUARD S A SAFETY SYSTEM

K141464 is an FDA 510(k) clearance for NOVAGUARD S A SAFETY SYSTEM, manufactured by West Pharmaceutical Services. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K141464 · West Pharmaceutical Services · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
99d
Days
Class 2
Risk

K141464 is an FDA 510(k) clearance for the NOVAGUARD S A SAFETY SYSTEM. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by West Pharmaceutical Services (Exton, US). The FDA issued a Cleared decision on September 10, 2014 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K141464

510(k) Number K141464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2014
Decision Date September 10, 2014
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - MEG Syringe, Antistick

All 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K141464.
ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
K140949 · Ultimed Incorporated · Feb 2015
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
K141640 · Shantou Wealy Medical Instrument Co.,Ltd · Nov 2014
SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION
K141664 · Rexam Healthcare · Oct 2014
SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
K132681 · Sol-Millennium Medical, Inc. · May 2014
TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE
K131531 · Anhui Tiankang Medical Products Co., Ltd. · May 2014
ULTRASAFE PLUS PASSIVE NEEDLE GUARD
K123743 · Safety Syringes, Inc. · Mar 2013
K141464 · NOVAGUARD S A SAFETY SYSTEM
Download PDF FDA Summary West Pharmaceutical S…