IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (26
Summary
Drägerwerk AG & Co. KGaA received 510(k) clearance for IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559), a DSA device. Cleared on 2025-12-01.
Details
Source
510(k) Clearance
External ID
K252827
Action Date
2025-12-01
Status
Traditional
Category
device
Product Code
DSA
Product Description
IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559). Product code: DSA.
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. Drägerwerk AG & Co. KGaA has received 5 total clearances in our database.
Drägerwerk AG & Co. KGaA has 5 FDA actions in our database, including 5 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 Drägerwerk AG & Co. KGaA have FDA actions?
Drägerwerk AG & Co. KGaA has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252827" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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