Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors— 510(k) K181738

Substantially Equivalent

Surgical Instrument Service and Savings Inc (Dba Medline

FDA 510(k) clearance K181738 for Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors, Substantially Equivalent on 2019-03-22. Applicant: Surgical Instrument Service and Savings Inc (Dba Medline.

Clearance details

Applicant: Surgical Instrument Service and Savings Inc (Dba Medline
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2018-07-02
Decision date: 2019-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.