TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
Summary
Imperative Care, Inc. received 510(k) clearance for TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform, a QJP device. Cleared on 2021-09-20.
Details
Source
510(k) Clearance
External ID
K212224
Action Date
2021-09-20
Status
Special
Category
device
Product Code
QJP
Product Description
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform. Product code: QJP.
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. Imperative Care, Inc. has received 11 total clearances in our database.
Imperative Care, Inc. has 12 FDA actions in our database, including 1 recall and 11 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 Imperative Care, Inc. have FDA actions?
Imperative Care, Inc. has 12 FDA actions in our database, including 1 recall and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212224" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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