IntelliVue Measurement Rack 6000 (867317) (K253654): 510(k) cleared Mar 30, 2026

IntelliVue Measurement Rack 6000 (867317)

Philips Medizin Systeme Böblingen GmbH · Mar 30, 2026 · K253654

FDA cleared the IntelliVue Measurement Rack 6000 (867317) from Philips Medizin Systeme Böblingen GmbH on Mar 30, 2026 under K253654, a traditional 510(k). The device falls under product code MSX, System, Network And Communication, Physiological Monitors, regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 20, 2025. The decision came 130 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Philips Medizin Systeme Böblingen GmbH has 5 other decisions in the tracker over the last 12 months: K252821 (Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)), K253887 (Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)), K252726 (IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)), K251702 (IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )).

Questions & Answers

What did FDA clear under K253654?

K253654 is the FDA 510(k) for IntelliVue Measurement Rack 6000 (867317), submitted by Philips Medizin Systeme Böblingen GmbH. FDA's decision date was Mar 30, 2026, under product code MSX (System, Network And Communication, Physiological Monitors).

Who makes the IntelliVue Measurement Rack 6000 (867317)?

Philips Medizin Systeme Böblingen GmbH, based in Boeblingen, is the applicant of record for K253654.

How long did the K253654 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Mar 30, 2026, 130 days later.

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