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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter, tissue saturation
Regulation Description Oximeter.
Product CodeMUD
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 3
ISS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENT IMAGING
  SUBSTANTIALLY EQUIVALENT 1
KENT IMAGING INC
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MIMOSA DIAGNOSTICS INC
  SUBSTANTIALLY EQUIVALENT 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ODI MEDICAL AS
  SUBSTANTIALLY EQUIVALENT 1
SPECTROS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VIOPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 107 107
2020 50 50
2021 27 27
2022 52 52
2023 73 73
2024 140 140
2025 112 112

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 143 143
Incorrect, Inadequate or Imprecise Result or Readings 97 97
Incorrect Measurement 88 88
Failure to Analyze Signal 66 66
Patient Device Interaction Problem 47 47
Communication or Transmission Problem 45 45
Erratic or Intermittent Display 39 39
Manufacturing, Packaging or Shipping Problem 39 39
High Readings 38 38
Defective Device 29 29
Image Display Error/Artifact 28 28
Device Alarm System 26 26
Adverse Event Without Identified Device or Use Problem 16 16
Patient-Device Incompatibility 14 14
Use of Device Problem 11 11
Contamination /Decontamination Problem 10 10
Device Damaged Prior to Use 8 8
Display or Visual Feedback Problem 8 8
Temperature Problem 8 8
Insufficient Information 7 7
Sensing Intermittently 7 7
Failure to Power Up 6 6
Appropriate Term/Code Not Available 6 6
Loss of or Failure to Bond 6 6
Material Split, Cut or Torn 5 5
Output Problem 4 4
Data Problem 4 4
Detachment of Device or Device Component 3 3
Defective Component 2 2
Thermal Decomposition of Device 2 2
Device Emits Odor 2 2
Ambient Noise Problem 2 2
Device Fell 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unable to Obtain Readings 1 1
Battery Problem 1 1
Mechanical Problem 1 1
Application Program Problem: Parameter Calculation Error 1 1
No Apparent Adverse Event 1 1
Failure to Shut Off 1 1
Connection Problem 1 1
Human-Device Interface Problem 1 1
Device Slipped 1 1
Loose or Intermittent Connection 1 1
Device Displays Incorrect Message 1 1
Failure to Run on Battery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 320 320
No Consequences Or Impact To Patient 116 116
Insufficient Information 45 45
Pressure Sores 43 43
Unspecified Tissue Injury 15 15
Burn(s) 13 13
No Patient Involvement 13 13
No Information 9 9
No Known Impact Or Consequence To Patient 9 9
Injury 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Death 3 3
Inflammation 3 3
Low Oxygen Saturation 3 3
Skin Irritation 2 2
Localized Skin Lesion 2 2
Rash 2 2
Skin Tears 2 2
Superficial (First Degree) Burn 1 1
Stroke/CVA 1 1
Diaphoresis 1 1
Burn, Thermal 1 1
Edema 1 1
Blister 1 1
Skin Discoloration 1 1
Hemorrhage, Cerebral 1 1
Ecchymosis 1 1
Tissue Breakdown 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien II Apr-30-2024
2 Edwards Lifesciences, LLC II Mar-30-2022
3 KENT IMAGING, INC. II Jan-25-2024
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