Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
oximeter, reprocessed
Definition
same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product Code
NLF
Regulation Number
870.2700
Device Class
2
Premarket Reviews
Manufacturer
Decision
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
2
MIDWEST REPROCESSING CENTER LLC
SUBSTANTIALLY EQUIVALENT
1
RENU MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
STERILMED, INC.
SUBSTANTIALLY EQUIVALENT
2
1. K092368
REPROCESSED PULSE OXIMETER SENSORS
2. K102560
REPROCESSED PULSE OXIMETER SENSORS
STRYKER SUSTAINABILITY SOLUTIONS
SUBSTANTIALLY EQUIVALENT
2
SURGICAL INSTRUMENT AND SAVINGS INC (DBA MEDLINE RENEWAL)
SUBSTANTIALLY EQUIVALENT
1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
3
3
2016
4
4
2017
4
4
2018
8
8
2019
11
11
2020
2
2
2021
1
1
2022
2
2
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Device
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Temperature Problem
4
4
Patient Device Interaction Problem
2
2
Adhesive Too Strong
2
2
Defective Component
2
2
Out-Of-Box Failure
2
2
Device Displays Incorrect Message
2
2
Device Operates Differently Than Expected
2
2
Unable to Obtain Readings
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Break
2
2
Fracture
2
2
Difficult to Insert
1
1
Incorrect Measurement
1
1
Melted
1
1
No Device Output
1
1
Peeled/Delaminated
1
1
Thermal Decomposition of Device
1
1
Detachment Of Device Component
1
1
False Reading From Device Non-Compliance
1
1
Material Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Sensing Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Protrusion/Extrusion
1
1
Packaging Problem
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
18
18
Skin Inflammation/ Irritation
4
4
Inflammation
3
3
No Patient Involvement
3
3
Burn(s)
3
3
Purulent Discharge
2
2
Injury
2
2
No Information
2
2
No Code Available
1
1
Device Embedded In Tissue or Plaque
1
1
Foreign Body In Patient
1
1
Rash
1
1
Numbness
1
1
Confusion/ Disorientation
1
1
Blood Loss
1
1
Erythema
1
1
Unspecified Infection
1
1
Insufficient Information
1
1
-
-