Cleared Traditional

K050505 - DEPOTONE

K050505 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 Traditional 510(k) pathway after a 36-day FDA review.

K050505 · Imprint Pharmaceuticals Limited · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
36d
Days
Class 2
Risk

K050505 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 April 5, 2005 after a review of 36 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 - K050505

510(k) Number K050505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2005
Decision Date April 05, 2005
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
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

Tuv Rheinland of North America, Inc.
TAMAS BORSI

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 658
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K050505.
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
STAT MEDICAL PEN NEEDLE
K042917 · Emergogroup, Inc. · Apr 2005
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

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.

K050505 · DEPOTONE
Download PDF FDA Summary Imprint Pharmaceutica…