Masimo CARESCAPE SpO2 Masimo with SpHb
Summary
Masimo Corporation received 510(k) clearance for Masimo CARESCAPE SpO2 Masimo with SpHb, a DQA device. Cleared on 2022-08-04.
Details
Source
510(k) Clearance
External ID
K221953
Action Date
2022-08-04
Status
Special
Category
device
Product Code
DQA
Product Description
Masimo CARESCAPE SpO2 Masimo with SpHb. Product code: DQA.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Masimo Corporation has received 17 total clearances in our database.
Masimo Corporation has 25 FDA actions in our database, including 8 recalls and 17 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 Masimo Corporation have FDA actions?
Masimo Corporation has 25 FDA actions in our database, including 8 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221953" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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