510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K885349Substantially Equivalent

Sonomicrometer, Ultrasonic Dimension System, Card.

Sonotek Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885349 is the FDA 510(k) clearance record for SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD., a class II device, cleared for Sonotek Corp. on under FDA product code DXK (Echocardiograph). FDA records list one 510(k) clearance for Sonotek Corp. As of , FDA records show no recalls naming K885349.

Clearance record

Decision date
Received
(176 days to decision)
Product code
DXK Echocardiograph
Regulation
21 CFR 870.2330
Device class
Class II
Review panel
Cardiovascular
Applicant
Sonotek Corp. 7925 Silverton Ave., Suite 509, San Diego CA
Third party review
No

Clearances, product code DXK

Trailing 12 months

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

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