510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K952837Substantially Equivalent

Darwin Hypodermic Safety System (Dhss)

Emk Enterprises, LLC, Wilmington NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952837 is the FDA 510(k) clearance record for DARWIN HYPODERMIC SAFETY SYSTEM (DHSS), a class II device, cleared for Emk Enterprises, LLC on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list one 510(k) clearance for Emk Enterprises, LLC. As of , FDA records show no recalls naming K952837.

Clearance record

Decision date
Received
(225 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Emk Enterprises, LLC 218 Princess St., Wilmington NC
510(k) summary
Statement
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260