510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K221568Substantially Equivalent

KOLO Evolution XHD Series Ultrasound Diagnostic System

Kolo Medical (Suzhou) Co., Ltd., Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221568 is the FDA 510(k) clearance record for KOLO Evolution XHD Series Ultrasound Diagnostic System, a class II device, cleared for Kolo Medical (Suzhou) Co., Ltd. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list one 510(k) clearance for Kolo Medical (Suzhou) Co., Ltd. As of , FDA records show no recalls naming K221568.

Clearance record

Decision date
Received
(104 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Kolo Medical (Suzhou) Co., Ltd. Rm. 303-305 And 504, Bldg. A5, # 218 Xinghu St., Suzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYN

Trailing 12 months
53 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20261