510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771211Substantially Equivalent

Doppler (Utd-5 & Utd-6)

Terumo America, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771211 is the FDA 510(k) clearance record for DOPPLER (UTD-5 & UTD-6), a class II device, cleared for Terumo America, Inc. on under FDA product code HEK (Monitor, Heart Sound, Fetal, Ultrasonic). FDA records list 31 510(k) clearances for Terumo America, Inc., from to . As of , FDA records show no recalls naming K771211.

Clearance record

Decision date
Received
(9 days to decision)
Product code
HEK Monitor, Heart Sound, Fetal, Ultrasonic
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Terumo America, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HEK

Trailing 12 months

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

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