510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101960Substantially Equivalent

Sonotrax Series Ultrasonic Pocket Doppler

Edan Instruments, Inc., Shenzhen, CN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101960 is the FDA 510(k) clearance record for SONOTRAX SERIES ULTRASONIC POCKET DOPPLER, a class II device, cleared for Edan Instruments, Inc. on under FDA product code HEP (Monitor, Blood-Flow, Ultrasonic). FDA records list 94 510(k) clearances for Edan Instruments, Inc., from to . As of , FDA records show no recalls naming K101960.

Clearance record

Decision date
Received
(29 days to decision)
Product code
HEP Monitor, Blood-Flow, Ultrasonic
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Edan Instruments, Inc. 3/F-B, Nanshan Medical, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HEP

Trailing 12 months

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

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