TrueFit Bolus; TrueFlex Bolus
Summary
Adaptiiv Medical Technologies, Inc. received 510(k) clearance for TrueFit Bolus; TrueFlex Bolus, a MUJ device. Cleared on 2024-10-23.
Details
Source
510(k) Clearance
External ID
K243057
Action Date
2024-10-23
Status
Special
Category
device
Product Code
MUJ
Product Description
TrueFit Bolus; TrueFlex Bolus. Product code: MUJ.
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. Adaptiiv Medical Technologies, Inc. has received 2 total clearances in our database.
Adaptiiv Medical Technologies, Inc. has 2 FDA actions in our database, including 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 Adaptiiv Medical Technologies, Inc. have FDA actions?
Adaptiiv Medical Technologies, Inc. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243057" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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