Cleared Special

K061032 - DEPOTONE

K061032 is an FDA 510(k) clearance for DEPOTONE, manufactured by Imprint Pharmaceuticals Limited. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 68-day FDA review.

K061032 · Imprint Pharmaceuticals Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
68d
Days
Class 2
Risk

K061032 is an FDA 510(k) clearance for the DEPOTONE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Imprint Pharmaceuticals Limited (East Molesey, Surrey, GB). The FDA issued a Cleared decision on June 21, 2006 after a review of 68 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Imprint Pharmaceuticals Limited devices

FDA 510(k) Submission Details - K061032

510(k) Number K061032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2006
Decision Date June 21, 2006
Days to Decision 68 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 129d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 386
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K061032.
MEDLINE HYPODERMIC NEEDLES
K062984 · Medline Industries, Inc. · Nov 2006
HUMERAL HEAD, MANUAL DRIVER
K062422 · Vidacare Corporation · Nov 2006
29G AND 30G K-PACK II NEEDLE
K062608 · Terumo Europe N.V. · Sep 2006
BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
K052843 · Busse Hospital Disposables, Inc. · Apr 2006
BD AUTOSHIELD PEN NEEDLE
K060007 · Becton, Dickinson & CO · Mar 2006
EZ-IO
K052408 · Vidacare Corporation · Nov 2005