510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861710Substantially Equivalent

Model Ust-Ssd 880L1-5 Tranesophageal Phased Array

Johnson & Johnson Professionals, Inc., Ramsey NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861710 is the FDA 510(k) clearance record for MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY, a class II device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code DXK (Echocardiograph). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K861710.

Clearance record

Decision date
Received
(65 days to decision)
Product code
DXK Echocardiograph
Regulation
21 CFR 870.2330
Device class
Class II
Review panel
Cardiovascular
Applicant
Johnson & Johnson Professionals, Inc. 69 Spring St., Ramsey NJ
Third party review
No

Clearances, product code DXK

Trailing 12 months

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

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