510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K853209Substantially Equivalent

Compas 1

Cardiac Care Units, Inc., Van Nuys CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853209 is the FDA 510(k) clearance record for COMPAS 1, a class II device, cleared for Cardiac Care Units, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list one 510(k) clearance for Cardiac Care Units, Inc. As of , FDA records show no recalls naming K853209.

Clearance record

Decision date
Received
(97 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiac Care Units, Inc. 6911 Hayvenhurst Ave., Van Nuys CA
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI 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 DSI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260