Darwin Hypodermic Safety System (DHSS)

by Emk Enterprises, LLC

510(k) K952837

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

510(k) K952837↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK952837	Date30 Jan 1996Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K952837
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, 6 Oct 2026

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

The Darwin Hypodermic Safety System (DHSS) is a hypodermic single lumen needle, a device designed for injecting fluids into or withdrawing fluids from areas of the body beneath the skin's surface. It comprises a metal tube, sharpened at one end, with the other end connected to a female connector (hub) that interfaces with a male connector (nozzle) of a piston syringe or similar device.

This device is a Class 2 General Hospital device. It was cleared through the Traditional 510(k) pathway and received a "Substantially Equivalent" decision from the FDA.