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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oximeter
Regulation Description Oximeter.
Product CodeDQA
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
ATHENA GTX
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 5
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
BEIJING SAFE HEART TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIO MEDICAL TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BLUEPOINT MEDICAL GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
DELBIO INC.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HONEYWELL INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
NONIN
  SUBSTANTIALLY EQUIVALENT 5
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
ORSENSE
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN BIOPHOTONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNIMED
  SUBSTANTIALLY EQUIVALENT 1
XHALE, INC.
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect Measurement 1726
Display or Visual Feedback Problem 906
Device Operates Differently Than Expected 505
Failure To Run On AC/DC 404
Device Stops Intermittently 390
Low Readings 281
Inappropriate or Unexpected Reset 170
Device Sensing Problem 147
Sensing Intermittently 146
No Display / Image 136
Device Alarm System 133
No Audible Alarm 130
Power Problem 102
Patient-Device Incompatibility 98
High Readings 79
Battery Problem 74
Unable to Obtain Readings 66
Contamination / decontamination Problem 56
Adverse Event Without Identified Device or Use Problem 52
Erratic or Intermittent Display 45
Device Displays Incorrect Message 42
Poor Quality Image 36
Image Display Error / Artifact 36
Break 34
Component Missing 33
Loose or Intermittent Connection 26
Premature Discharge of Battery 25
Charging Problem 23
No Device Output 21
Defective Alarm 19
Incorrect, Inadequate or Imprecise Result or Readings 18
Material Integrity Problem 17
Failure to Charge 17
Noise, Audible 17
Failure to Sense 16
Battery 14
Biological Environmental Factor 14
Low Battery 14
Sparking 14
Temperature Problem 13
Inappropriate Shock 13
Thermal Decomposition of Device 13
Low Audible Alarm 13
Failure to Run on Battery 11
Insufficient Information 11
Overheating of Device 11
Appropriate Term/Code Not Available 11
Failure to Power Up 10
Detachment Of Device Component 9
Display 9
Invalid Sensing 9
Device Emits Odor 9
False Alarm 8
Failure To Adhere Or Bond 8
Mechanical Problem 7
Loss of Power 7
Output Problem 7
Missing Information 6
False Reading From Device Non-Compliance 6
Signal Artifact 6
Smoking 6
Use of Device Problem 5
Computer Operating System Problem 5
Incorrect Or Inadequate Test Results 5
Human-Device Interface Problem 5
Device Difficult to Program or Calibrate 5
Disconnection 4
Fire 4
Nonstandard device 4
Improper or Incorrect Procedure or Method 4
Device Operational Issue 4
Data Problem 4
Screen 4
Packaging Problem 4
Material Separation 3
Reset Problem 3
Image Orientation Incorrect 3
Improper Device Output 3
Electro-Static Discharge 3
False Device Output 3
Charred 3
Device Inoperable 3
Issue With Displayed Error Message 3
Electrical /Electronic Property Problem 3
Device Damaged Prior to Use 3
Defective Component 2
Cable 2
Computer Software Problem 2
High Test Results 2
Failure to Advance 2
Component or Accessory Incompatibility 2
Device Dislodged or Dislocated 2
Improper Alarm 2
Deformation Due to Compressive Stress 2
Melted 2
Unintended Ejection 2
Defective Device 2
Programming Issue 1
Out-Of-Box Failure 1
Therapeutic or Diagnostic Output Failure 1
Total Device Problems 6402

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Feb-02-2017
2 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Jul-27-2015
3 Masimo Corporation II Nov-25-2015
4 Masimo Corporation II Nov-13-2014
5 Merge Healthcare, Inc. II Jun-29-2017
6 Nonin Medical, Inc II Mar-28-2017
7 Nonin Medical, Inc II Dec-31-2014
8 Oridion Medical 1987 Ltd. II Oct-03-2018
9 Spacelabs Healthcare Inc II Jun-18-2014
10 Xhale Assurance, Inc. II Jul-30-2019

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