Cleared Special

K033794 - ULTICARE DISPOSABLE SYRINGE 3 ML/CC

K033794 is an FDA 510(k) clearance for ULTICARE DISPOSABLE SYRINGE 3 ML/CC, manufactured by Ultimed, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 25-day FDA review.

K033794 · Ultimed, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
25d
Days
Class 2
Risk

K033794 is an FDA 510(k) clearance for the ULTICARE DISPOSABLE SYRINGE 3 ML/CC. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Ultimed, Inc. (Laconner, US). The FDA issued a Cleared decision on December 30, 2003 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033794

510(k) Number K033794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2003
Decision Date December 30, 2003
Days to Decision 25 days
Submission Type Special
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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
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 - FMF Syringe, Piston

All 627
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K033794.
PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
K033739 · Physician Industries, Inc. · Jul 2004
AUTODETECT SYRINGE
K041590 · Indigo Orb, Inc. · Jun 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · Vascular Solutions, Inc. · Feb 2004
KACEY INSULIN SYRINGE
K033166 · Kacey, Inc. · Dec 2003
NIPRO DISPOSABLE SYRINGES
K030683 · Nipro Medical Corp. · Oct 2003
AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE
K031394 · American Syringe Company · Jul 2003
K033794 · ULTICARE DISPOSABLE SYRINGE 3 ML/CC
Download PDF FDA Summary Ultimed, Inc.