Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)— 510(k) K252821
Substantially EquivalentPhilips Medizin Systeme Böblingen GmbH
FDA 510(k) clearance K252821 for Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T), Substantially Equivalent on 2026-05-29. Applicant: Philips Medizin Systeme Böblingen GmbH. Device class: 2.
Summary
Philips Medizin Systeme Böblingen's record covers two Reusable Adult SpO2 Clip Sensors, listed as 3m (M1196A) and 0.9m (M1196T). The product code is DQA, oximeters.
Class II, 21 CFR 870.2700. The Anesthesiology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Philips filed from Böblingen, Germany. Review took 267 calendar days (September 4, 2025 to May 29, 2026).
Clearance details
- Applicant
- Philips Medizin Systeme Böblingen GmbH
- Product code
- Product code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Böblingen, DE
Recent devices under product code DQA
view all- K260490 — Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Philips Medizin Systeme Böblingen GmbH
view all- K253654 — IntelliVue Measurement Rack 6000 (867317)
- K251702 — IntelliVue Patient Monitor MX750 +2 more
- K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
- K242962 — Telemetry Monitor 5500 Release 4.0 (867232)
- K241890 — Philips Holter Analysis System
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.