510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190175Substantially Equivalent

S-Mak Xl

Merit Medical Systems, Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190175 is the FDA 510(k) clearance record for S-MAK XL, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code DRE (Dilator, Vessel, For Percutaneous Catheterization). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K190175.

Clearance record

Decision date
Received
(68 days to decision)
Product code
DRE Dilator, Vessel, For Percutaneous Catheterization
Regulation
21 CFR 870.1310
Device class
Class II
Review panel
Cardiovascular
Applicant
Merit Medical Systems, Inc. 1600 W. Merit Pkwy., South Jordan UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRE

Trailing 12 months
2 clearances under product code DRE 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 DRE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260