Cleared Traditional

K140949 - ULTICARE SAFETY SYRINGE WITH REMOVABLE ...

K140949 is an FDA 510(k) clearance for ULTICARE SAFETY SYRINGE WITH REMOVABLE ..., manufactured by Ultimed Incorporated. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K140949 · Ultimed Incorporated · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
301d
Days
Class 2
Risk

K140949 is an FDA 510(k) clearance for the ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Ultimed Incorporated (Minneapolis, US). The FDA issued a Cleared decision on February 9, 2015 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Ultimed Incorporated devices

FDA 510(k) Submission Details - K140949

510(k) Number K140949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2014
Decision Date February 09, 2015
Days to Decision 301 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 129d · This submission: 301d
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 42
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K140949.
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
K183665 · Jiangsu Micsafe Medical Technology Co., Ltd. · Sep 2019
Greenmedi Safety Filter Syringe
K173743 · Sang-A Frontec Co., Ltd. · Jan 2019
Self-destruction Safety Syringes for Single Use
K180417 · Berpu Medical Technology Co., Ltd. · Aug 2018
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007