Cleared Traditional

K080600 - ULTIMED ULTICARE SAFETY SYRINGE

K080600 is an FDA 510(k) clearance for ULTIMED ULTICARE SAFETY SYRINGE, manufactured by Ultimed, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K080600 · Ultimed, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
114d
Days
Class 2
Risk

K080600 is an FDA 510(k) clearance for the ULTIMED ULTICARE SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Ultimed, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 25, 2008 after a review of 114 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 - K080600

510(k) Number K080600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date June 25, 2008
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
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 K080600.
INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
K092413 · Inviro Medical Devices, Inc. · Sep 2009
1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
K092430 · Inviro Medical Devices, Inc. · Sep 2009
1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
K080877 · Unilife Medical Solutions Limited · Oct 2008
JIERUI SYRINGES AND NEEDLES
K072739 · Shandong Weigao Group Medical Polymer Co., Ltd. · Mar 2008
NEEDLE-TRAP/NEEDLE SAFETY LABEL
K073206 · Schreiner Medipharm · Jan 2008
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007
K080600 · ULTIMED ULTICARE SAFETY SYRINGE
Download PDF FDA Summary Ultimed, Inc.