510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854041Substantially Equivalent

Cd-100 Cardiac Monitor

Cardio Display Corp., Westbury NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854041 is the FDA 510(k) clearance record for CD-100 CARDIAC MONITOR, a class II device, cleared for Cardio Display Corp. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 2 510(k) clearances for Cardio Display Corp., from to . As of , FDA records show no recalls naming K854041.

Clearance record

Decision date
Received
(97 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardio Display Corp. 2000 Shames Dr., Westbury NY
Third party review
No

Clearances, product code DRT

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