Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Trans
Summary
Stryker Sustainability Solutions received 510(k) clearance for Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2, a DQA device. Cleared on 2022-03-08.
Details
Source
510(k) Clearance
External ID
K211140
Action Date
2022-03-08
Status
Traditional
Category
device
Product Code
DQA
Product Description
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2. Product code: DQA.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 413 device clearances issued this month. Stryker Sustainability Solutions has received 11 total clearances in our database.
Stryker Sustainability Solutions has 46 FDA actions in our database, including 35 recalls and 11 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Stryker Sustainability Solutions have FDA actions?
Stryker Sustainability Solutions has 46 FDA actions in our database, including 35 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K211140" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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