Novii+ Wireless Patch System
Summary
Datex Ohmeda, Inc. received 510(k) clearance for Novii+ Wireless Patch System, a HGM device. Cleared on 2026-08-10.
Details
Source
510(k) Clearance
External ID
K254036
Action Date
2026-08-10
Status
Traditional
Category
device
Product Code
HGM
Product Description
Novii+ Wireless Patch System. Product code: HGM.
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 376 device clearances issued this month. Datex Ohmeda, Inc. has received 6 total clearances in our database.
Datex Ohmeda, Inc. has 30 FDA actions in our database, including 24 recalls and 6 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 Datex Ohmeda, Inc. have FDA actions?
Datex Ohmeda, Inc. has 30 FDA actions in our database, including 24 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K254036" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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