510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882018Substantially Equivalent

Medacord Pvl, Personal Vascular Laboratory

Medasonics, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882018 is the FDA 510(k) clearance record for MEDACORD PVL, PERSONAL VASCULAR LABORATORY, a class II device, cleared for Medasonics, Inc. on under FDA product code JAF (Monitor, Ultrasonic, Nonfetal). FDA records list 19 510(k) clearances for Medasonics, Inc., from to . As of , FDA records show no recalls naming K882018.

Clearance record

Decision date
Received
(131 days to decision)
Product code
JAF Monitor, Ultrasonic, Nonfetal
Regulation
21 CFR 892.1540
Device class
Class II
Review panel
Radiology
Applicant
Medasonics, Inc. 82 Pioneer Way, Mountain View CA
Third party review
No

Clearances, product code JAF

Trailing 12 months

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

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