Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheo
Summary
Smiths Medical Asd, Inc. received 510(k) clearance for Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula, a JOH device. Cleared on 2021-11-26.
Details
Source
510(k) Clearance
External ID
K210833
Action Date
2021-11-26
Status
Traditional
Category
device
Product Code
JOH
Product Description
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula. Product code: JOH.
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. Smiths Medical Asd, Inc. has received 2 total clearances in our database.
Smiths Medical Asd, Inc. has 164 FDA actions in our database, including 162 recalls and 2 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 Smiths Medical Asd, Inc. have FDA actions?
Smiths Medical Asd, Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K210833" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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