| Device Type ID | 209 |
| Device Name | Oximeter |
| Regulation Description | Oximeter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DQA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 209 |
| Device | Oximeter |
| Product Code | DQA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Oximeter. |
| CFR Regulation Number | 870.2700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
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 | 1647 |
Display Or Visual Feedback Problem | 858 |
Device Operates Differently Than Expected | 505 |
Failure To Run On AC/DC | 404 |
Device Stops Intermittently | 390 |
Low Readings | 213 |
Inappropriate Or Unexpected Reset | 152 |
Device Sensing Problem | 145 |
No Display / Image | 134 |
No Audible Alarm | 125 |
Device Alarm System | 119 |
Sensing Intermittently | 117 |
Power Problem | 101 |
Patient-Device Incompatibility | 98 |
Battery Problem | 71 |
Unable To Obtain Readings | 63 |
High Readings | 61 |
Adverse Event Without Identified Device Or Use Problem | 52 |
Erratic Or Intermittent Display | 44 |
Device Displays Incorrect Message | 40 |
Component Missing | 33 |
Image Display Error / Artifact | 27 |
Break | 26 |
Poor Quality Image | 24 |
Premature Discharge Of Battery | 24 |
Charging Problem | 23 |
Loose Or Intermittent Connection | 23 |
Contamination / Decontamination Problem | 22 |
No Device Output | 21 |
Failure To Charge | 17 |
Defective Alarm | 16 |
Low Battery | 14 |
Biological Environmental Factor | 14 |
Battery | 14 |
Sparking | 14 |
Inappropriate Shock | 13 |
Material Integrity Problem | 13 |
Thermal Decomposition Of Device | 13 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 13 |
Low Audible Alarm | 13 |
Temperature Problem | 12 |
Noise, Audible | 12 |
Appropriate Term/Code Not Available | 11 |
Failure To Run On Battery | 11 |
Insufficient Information | 10 |
Overheating Of Device | 10 |
Display | 9 |
Detachment Of Device Component | 9 |
Invalid Sensing | 9 |
Failure To Sense | 9 |
Failure To Adhere Or Bond | 8 |
Failure To Power Up | 8 |
Loss Of Power | 7 |
False Alarm | 7 |
False Reading From Device Non-Compliance | 6 |
Signal Artifact | 6 |
Smoking | 5 |
Device Difficult To Program Or Calibrate | 5 |
Human-Device Interface Problem | 5 |
Device Emits Odor | 5 |
Output Problem | 5 |
Incorrect Or Inadequate Test Results | 5 |
Packaging Problem | 4 |
Mechanical Problem | 4 |
Nonstandard Device | 4 |
Computer Operating System Problem | 4 |
Device Operational Issue | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Data Problem | 4 |
Screen | 4 |
Use Of Device Problem | 3 |
Electro-Static Discharge | 3 |
Device Inoperable | 3 |
Issue With Displayed Error Message | 3 |
Improper Device Output | 3 |
Fire | 3 |
False Device Output | 3 |
Material Separation | 3 |
Reset Problem | 3 |
Charred | 3 |
Disconnection | 3 |
Image Orientation Incorrect | 3 |
Computer Software Problem | 2 |
Defective Device | 2 |
Improper Alarm | 2 |
Component Or Accessory Incompatibility | 2 |
Cable | 2 |
Defective Component | 2 |
Melted | 2 |
Unintended Ejection | 2 |
Deformation Due To Compressive Stress | 2 |
Device Dislodged Or Dislocated | 2 |
Electrical /Electronic Property Problem | 2 |
High Test Results | 2 |
Failure To Reset | 1 |
Unintended Power Up | 1 |
Connection Problem | 1 |
Output Below Specifications | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
No Apparent Adverse Event | 1 |
| Total Device Problems | 5988 |
| 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 |