510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K955514Substantially Equivalent

Sharps Safe 1.5 & Sharps Safe 2.0

Dura-Vac Products, Ventura CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955514 is the FDA 510(k) clearance record for SHARPS SAFE 1.5 & SHARPS SAFE 2.0, a class II device, cleared for Dura-Vac Products on under FDA product code MMK (Container, Sharps). FDA records list one 510(k) clearance for Dura-Vac Products. As of , FDA records show no recalls naming K955514.

Clearance record

Decision date
Received
(241 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Dura-Vac Products 4464 Mcgrath St., #114, Ventura CA
510(k) summary
Summary
Third party review
No

Clearances, product code MMK

Trailing 12 months
3 clearances under product code MMK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260