Cleared Traditional

K042907 - NEEDLE INCAPACITATOR (NEEDLE GUARD)

K042907 is an FDA 510(k) clearance for NEEDLE INCAPACITATOR (NEEDLE GUARD), manufactured by Pdmp, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K042907 · Pdmp, Inc. · General Hospital
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Dec 2004
Decision
62d
Days
Class 2
Risk

K042907 is an FDA 510(k) clearance for the NEEDLE INCAPACITATOR (NEEDLE GUARD). Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Pdmp, Inc. (Crofton, US). The FDA issued a Cleared decision on December 22, 2004 after a review of 62 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 - K042907

510(k) Number K042907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2004
Decision Date December 22, 2004
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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

Entela, Inc.
N.E. DEVINE, JR.

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 686
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K042907.
NOVOFINE AUTOCOVER 30G X 8MM
K050106 · Novo Nordisk, Inc. · Mar 2005
PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
K043490 · Vidacare Corporation · Feb 2005
MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE
K043397 · Becton, Dickinson & CO · Dec 2004
VASCULAR SOLUTIONS SCLERO-KIT
K043019 · Vascular Solutions, Inc. · Dec 2004
SAFE T RETRACTABLE BLOOD COLLECTION DEVICE
K041941 · Safe T Medical Devices, Ltd. · Sep 2004
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
K041399 · Smiths Medical Asd, Inc. · Jul 2004

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.

K042907 · NEEDLE INCAPACITATOR (NEEDLE GUARD)
Download PDF Pdmp, Inc.