510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854734Substantially Equivalent

Model 5320 Ted Sequential Comp. De. Comp. Limb Sle

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

K854734 is the FDA 510(k) clearance record for MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE, a class II device, cleared for Medasonics, Inc. on under FDA product code DRM (Compressor, Cardiac, External). FDA records list 19 510(k) clearances for Medasonics, Inc., from to . As of , FDA records show no recalls naming K854734.

Clearance record

Decision date
Received
(77 days to decision)
Product code
DRM Compressor, Cardiac, External
Regulation
21 CFR 870.5200
Device class
Class II
Review panel
Cardiovascular
Applicant
Medasonics, Inc. 82 Pioneer Way, Mountain View CA
Third party review
No

Clearances, product code DRM

Trailing 12 months

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

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