510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K962918Substantially Equivalent

Lidco System

Lidco, Ltd., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962918 is the FDA 510(k) clearance record for LIDCO SYSTEM, a class II device, cleared for Lidco, Ltd. on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list one 510(k) clearance for Lidco, Ltd. As of , FDA records show no recalls naming K962918.

Clearance record

Decision date
Received
(925 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
Lidco, Ltd. 16809 Briardale Rd., Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code DXG

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