Cleared Traditional

K050464 - ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2

K050464 is an FDA 510(k) clearance for ULTRACARE DISPOSABLE PEN NEEDLES, manufactured by Ultimed, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K050464 · Ultimed, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
77d
Days
Class 2
Risk

K050464 is an FDA 510(k) clearance for the ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Ultimed, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 11, 2005 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K050464

510(k) Number K050464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2005
Decision Date May 11, 2005
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 632
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K050464.
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
K051783 · Artsana S.P.A · Oct 2005
BD PEN NEEDLE
K051899 · Becton, Dickinson & CO · Sep 2005
ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
K043249 · Atrion Medical Products, Inc. · May 2005
STAT MEDICAL PEN NEEDLE
K042917 · Emergogroup, Inc. · Apr 2005
DEPOTONE
K050505 · Imprint Pharmaceuticals Limited · Apr 2005
NOVOFINE AUTOCOVER 30G X 8MM
K050106 · Novo Nordisk, Inc. · Mar 2005
K050464 · ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
Download PDF FDA Summary Ultimed, Inc.