Cleared Traditional

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)

K252827 · Dr?gerwerk AG & Co KGaA · Cardiovascular
Dec 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K252827 is an FDA 510(k) clearance for the 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 Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Dr?gerwerk AG & Co KGaA (Luebeck, DE). The FDA issued a Cleared decision on December 1, 2025, 87 days after receiving the submission on September 5, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K252827 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2025
Decision Date December 01, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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