Cleared Abbreviated

K073122 - MONOJECT HYPODERMIC NEEDLE

K073122 is an FDA 510(k) clearance for MONOJECT HYPODERMIC NEEDLE, manufactured by Covidien Lp, Formerly Registered AS Tyco Healthcar. The device is a Class 2 General Hospital device with product code FMI cleared through the Abbreviated 510(k) pathway after a 15-day FDA review.

K073122 · Covidien Lp, Formerly Registered AS Tyco Healthcar · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
15d
Days
Class 2
Risk

K073122 is an FDA 510(k) clearance for the MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Covidien Lp, Formerly Registered AS Tyco Healthcar (Mansfield, US). The FDA issued a Cleared decision on November 21, 2007 after a review of 15 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Covidien Lp, Formerly Registered AS Tyco Healthcar devices

FDA 510(k) Submission Details - K073122

510(k) Number K073122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2007
Decision Date November 21, 2007
Days to Decision 15 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Standards-based clearance path.

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 279
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K073122.
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
K100209 · Becton, Dickinson & CO · Feb 2010
K-PACK II NEEDLE - 29G THIN WALL
K082820 · Terumo Europe N.V. · Oct 2008
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
K073188 · Smiths Medical Asd, Inc. · Feb 2008
STERICAN HYPODERMIC NEEDLES
K072247 · B.Braun Medical, Inc. · Nov 2007
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
K071998 · Arrow Intl., Inc. · Sep 2007
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
K071785 · Smiths Medical Asd, Inc. · Aug 2007