510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002067Substantially Equivalent

Radianalyzer, Model 12710

Radi Medical Systems AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002067 is the FDA 510(k) clearance record for RADIANALYZER, MODEL 12710, a class II device, cleared for Radi Medical Systems AB on under FDA product code DSK (Computer, Blood-Pressure). FDA records list 24 510(k) clearances for Radi Medical Systems AB, from to . As of , FDA records show no recalls naming K002067.

Clearance record

Decision date
Received
(188 days to decision)
Product code
DSK Computer, Blood-Pressure
Regulation
21 CFR 870.1110
Device class
Class II
Review panel
Cardiovascular
Applicant
Radi Medical Systems AB Palmbladsgatan 10, Uppsala, SE
510(k) summary
Summary
Third party review
No

Clearances, product code DSK

Trailing 12 months

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

FDA records show no clearances under product code DSK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DSK, 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