Radianalyzer, Model 12710

by Radi Medical Systems AB 510(k)

Active United States

510(k) K022188

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK022188	Date3 Oct 2002Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K022188
FDA Product Code: DQK

Device Class: Class II
Regulation: 21 CFR Part 870.1425
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Other devices from Radi Medical Systems AB

Femostop, Femostop Pump

Class II
Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720

Class II
Femostop Femoral Compression System

Class II
Quantien Measurement System

Class II
Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable

Class II
Modification to: Radianalyzer, Model 12711

Class II

See all devices from Radi Medical Systems AB →