Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, network and communication, physiological monitors
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Product CodeMSX
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRSTRIP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALERTWATCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOFOURMIS SINGAPORE PTE., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORSANO HEALTH B.V.
  SUBSTANTIALLY EQUIVALENT 1
CURRENT HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CURRENT HEALTH , LTD.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
HINLAB SAS
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIBEL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIGERCONNECT
  SUBSTANTIALLY EQUIVALENT 1
VISICU, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZYTER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 17 17
2022 18 18
2023 10 10
2024 32 33
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 44 44
No Audible Alarm 32 32
Alarm Not Visible 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Defective Alarm 4 5
Wireless Communication Problem 3 3
Intermittent Communication Failure 3 3
Communication or Transmission Problem 2 3
No Visual Prompts/Feedback 2 2
Delayed Alarm 2 2
No Device Output 2 2
Insufficient Information 1 1
Patient Data Problem 1 1
High Readings 1 1
Misconnection 1 1
No Audible Prompt/Feedback 1 1
Detachment of Device or Device Component 1 1
Low Audible Alarm 1 1
Protective Measures Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 65 65
No Clinical Signs, Symptoms or Conditions 32 33
Asystole 5 5
Cardiac Arrest 3 3
Chest Pain 2 2
Death 1 1
Respiratory Arrest 1 1
Tachycardia 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mindray DS USA, Inc. dba Mindray North America II Dec-12-2025
2 Mindray DS USA, Inc. dba Mindray North America III Jul-21-2021
3 Mindray DS USA, Inc. dba Mindray North America II Mar-15-2021
4 Philips North America II Mar-27-2024
5 Philips North America Llc II Feb-01-2022
-
-