Lyka® PORT Needle Free Access Device (4170Y)
Summary
Quest Medical, Inc. received 510(k) clearance for Lyka® PORT Needle Free Access Device (4170Y), a FPA device. Cleared on 2024-12-18.
Details
Source
510(k) Clearance
External ID
K241058
Action Date
2024-12-18
Status
Traditional
Category
device
Product Code
FPA
Product Description
Lyka® PORT Needle Free Access Device (4170Y). Product code: FPA.
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 413 device clearances issued this month. Quest Medical, Inc. has received 3 total clearances in our database.
Quest Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 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 Quest Medical, Inc. have FDA actions?
Quest Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241058" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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