510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081821Substantially Equivalent

D.a.r.t. Pro Kit (D.a.r.t. Pro Handle and X-Tractor Tip)

Global Pathogen Solutions, Inc., Camas WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081821 is the FDA 510(k) clearance record for D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP), a class II device, cleared for Global Pathogen Solutions, Inc. on under FDA product code MMK (Container, Sharps). FDA records list one 510(k) clearance for Global Pathogen Solutions, Inc. As of , FDA records show no recalls naming K081821.

Clearance record

Decision date
Received
(67 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Global Pathogen Solutions, Inc. 9515 NE 312th Ave., Camas WA
510(k) summary
Summary PDF
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