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)
FDA 510(k) clearance K252827 · decided 2025-12-01
Clearance details
- K-number
- K252827
- Device name
- 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)
- Applicant
- Drägerwerk AG & Co. KGaA
- Decision
- Substantially Equivalent
- Date received
- 2025-09-05
- Decision date
- 2025-12-01
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DSA
- Device class
- 2
- Regulation number
- 870.2900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Luebeck, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.