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Depotone

by Imprint Pharmaceuticals Limited 2 variants

510(k) K050505

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050505 Date5 Apr 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Depotone is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. It is designed to interface with the male luer connector of a syringe or intravenous set.

The Depotone is supplied as a single-use device and is classified as a Class 2 medical device. It has been cleared by the FDA under the traditional clearance type with the product code FMI and k number K050505. The device is intended for use in a general hospital setting.

Other devices from Imprint Pharmaceuticals Limited

  • Depotone

    Class II

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Depotone used for?

    The Depotone is used for the injection and removal of fluids from below the surface of the skin in humans, and is intended for use in a general hospital setting.

  • Is the Depotone a single-use device?

    Yes, the Depotone is supplied as a single-use device, and is not intended for reuse.

  • How is the Depotone connected to other devices?

    The Depotone is designed to interface with the male luer connector of a syringe or intravenous set.