510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K051038Substantially Equivalent

506 Patient Monitor

Ciriticare Systems, Inc., Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051038 is the FDA 510(k) clearance record for 506 PATIENT MONITOR, a class II device, cleared for Ciriticare Systems, Inc. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list one 510(k) clearance for Ciriticare Systems, Inc. As of , FDA records show no recalls naming K051038.

Clearance record

Decision date
Received
(109 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
Ciriticare Systems, Inc. 20925 Crossroads Cir., Waukesha WI
510(k) summary
Summary PDF
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