510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080087Substantially Equivalent

Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular

Edan Instruments, Inc., Yonkers NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080087 is the FDA 510(k) clearance record for SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR, a class II device, cleared for Edan Instruments, Inc. on under FDA product code KNG (Monitor, Ultrasonic, Fetal). FDA records list 94 510(k) clearances for Edan Instruments, Inc., from to . As of , FDA records show no recalls naming K080087.

Clearance record

Decision date
Received
(60 days to decision)
Product code
KNG Monitor, Ultrasonic, Fetal
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Edan Instruments, Inc. 1 Odell Plz., Yonkers NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNG

Trailing 12 months
1 clearance under product code KNG in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNG, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260