Cleared Traditional

K043249 - ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE

K043249 is an FDA 510(k) clearance for ATRION NEEDLEVISE LARGE-BORE SHARPS SEC..., manufactured by Atrion Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K043249 · Atrion Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
183d
Days
Class 2
Risk

K043249 is an FDA 510(k) clearance for the ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Atrion Medical Products, Inc. (Arab, US). The FDA issued a Cleared decision on May 25, 2005 after a review of 183 days - an extended review 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: 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 - K043249

510(k) Number K043249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2004
Decision Date May 25, 2005
Days to Decision 183 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
54d slower than avg
Panel avg: 129d · This submission: 183d
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 597
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K043249.
POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM
K051992 · Vidacare Corporation · Oct 2005
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
K051783 · Artsana S.P.A · Oct 2005
BD PEN NEEDLE
K051899 · Becton, Dickinson & CO · Sep 2005
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
K050464 · Ultimed, Inc. · May 2005
STAT MEDICAL PEN NEEDLE
K042917 · Emergogroup, Inc. · Apr 2005
DEPOTONE
K050505 · Imprint Pharmaceuticals Limited · Apr 2005