Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S No
Summary
Shanghai Draeger Medical Instrument Co., Ltd. received 510(k) clearance for Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427), a MHX device. Cleared on 2026-04-10.
Details
Source
510(k) Clearance
External ID
K252250
Action Date
2026-04-10
Status
Traditional
Category
device
Product Code
MHX
Product Description
Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427). Product code: MHX.
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. Shanghai Draeger Medical Instrument Co., Ltd. has received 2 total clearances in our database.
Shanghai Draeger Medical Instrument Co., Ltd. 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 Shanghai Draeger Medical Instrument Co., Ltd. have FDA actions?
Shanghai Draeger Medical Instrument Co., Ltd. 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 "K252250" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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