Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

FDA cleared the Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) from Philips Medizin Systeme on May 1, 2026 under K253887, a traditional 510(k). The device falls under product code DQA, Oximeter, regulated at 21 CFR 870.2700 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 4, 2025. The decision came 148 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Philips Medizin Systeme 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)), K253654 (IntelliVue Measurement Rack 6000 (867317)), 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 )).