510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K000320Substantially Equivalent

Sonos Aires 600 (Sa-600)

Kpi Ultrasound, LLC, Rancho Domingeus CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000320 is the FDA 510(k) clearance record for SONOS AIRES 600 (SA-600), a class II device, cleared for Kpi Ultrasound, LLC on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list one 510(k) clearance for Kpi Ultrasound, LLC. As of , FDA records show no recalls naming K000320.

Clearance record

Decision date
Received
(90 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Kpi Ultrasound, LLC 18626 S. Wilmington Ave., Rancho Domingeus CA
510(k) summary
Summary
Third party review
No

Clearances, product code IYO

Trailing 12 months
8 clearances under product code IYO in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260