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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeNLF
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MIDWEST REPROCESSING CENTER LLC
  SUBSTANTIALLY EQUIVALENT 1
RENU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERILMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INSTRUMENT AND SAVINGS INC (DBA MEDLINE RENEWAL)
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201699  Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Se ...
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

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