510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240860Substantially Equivalent

EchoGo Amyloidosis (1.0)

Ultromics, Ltd., Oxford, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240860 is the FDA 510(k) clearance record for EchoGo Amyloidosis (1.0), a class II device, cleared for Ultromics Limited on under FDA product code SDJ (Adjunctive Cardiac Amyloidosis Status Indicator). FDA's definition for product code SDJ reads: "The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for...". FDA records list 6 510(k) clearances for Ultromics Limited, from to . As of , FDA records show no recalls naming K240860.

Clearance record

Decision date
Received
(232 days to decision)
Product code
SDJ Adjunctive Cardiac Amyloidosis Status Indicator
Regulation
21 CFR 870.2200
Device class
Class II
Review panel
Cardiovascular
Applicant
Ultromics Limited 4630 Kingsgate, Oxford, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SDJ

Trailing 12 months

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

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