Cleared Traditional

K042917 - STAT MEDICAL PEN NEEDLE

K042917 is an FDA 510(k) clearance for STAT MEDICAL PEN NEEDLE, manufactured by Emergogroup, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K042917 · Emergogroup, Inc. · General Hospital
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Apr 2005
Decision
182d
Days
Class 2
Risk

K042917 is an FDA 510(k) clearance for the STAT MEDICAL PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Emergogroup, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 22, 2005 after a review of 182 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 - K042917

510(k) Number K042917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2004
Decision Date April 22, 2005
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Bsi Healthcare
IBIM B TARIAH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 660
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K042917.
BD PEN NEEDLE
K051899 · Becton, Dickinson & CO · Sep 2005
ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
K043249 · Atrion Medical Products, Inc. · May 2005
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
K050464 · Ultimed, Inc. · May 2005
DEPOTONE
K050505 · Imprint Pharmaceuticals Limited · Apr 2005
NOVOFINE AUTOCOVER 30G X 8MM
K050106 · Novo Nordisk, Inc. · Mar 2005
PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
K043490 · Vidacare Corporation · Feb 2005

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K042917 · STAT MEDICAL PEN NEEDLE
Download PDF Emergogroup, Inc.