510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861378Substantially Equivalent

Ultramed Tf 122 Ultrason Vascu Imag & Doppler Syst

Ultramed, Inc., North Brunswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861378 is the FDA 510(k) clearance record for ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST, a class II device, cleared for Ultramed, Inc. on under FDA product code JOP (Transducer, Ultrasonic). FDA records list 5 510(k) clearances for Ultramed, Inc., from to . As of , FDA records show no recalls naming K861378.

Clearance record

Decision date
Received
(84 days to decision)
Product code
JOP Transducer, Ultrasonic
Regulation
21 CFR 870.2880
Device class
Class II
Review panel
Cardiovascular
Applicant
Ultramed, Inc. 2549 U.S. Rte. 1 Rd. #1, North Brunswick NJ
Third party review
No

Clearances, product code JOP

Trailing 12 months

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

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