510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180410Substantially Equivalent

Dosis SAM

Dosis, Inc., Los Altos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180410 is the FDA 510(k) clearance record for Dosis SAM, a class II device, cleared for Dosis, Inc. on under FDA product code MQS (System, Hemodialysis, Access Recirculation Monitoring). FDA records list one 510(k) clearance for Dosis, Inc. As of , FDA records show no recalls naming K180410.

Clearance record

Decision date
Received
(336 days to decision)
Product code
MQS System, Hemodialysis, Access Recirculation Monitoring
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dosis, Inc. 4388 El Camino Real, Unit 330, Los Altos CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQS

Trailing 12 months

FDA records hold no clearances under product code MQS in the trailing twelve months.

FDA records show no clearances under product code MQS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260