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Reusable Adult SpO2 Clip Sensor (3m) (M1196A)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252821

by Philips Medizin Systeme Böblingen GmbH

Identifiers

510(k) Number
K252821 FDA 510(k)
FDA Product Code
DQA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a reusable adult pulse oximetry sensor designed for non-invasive measurement of oxygen saturation (SpO₂) and pulse rate in patients weighing over 40 kg. Classified as a pulse oximeter sensor under regulatory nomenclature, it employs photoplethysmography to detect blood oxygen levels and heart rate via a clip applied to a finger or toe.

The sensor is supplied as a reusable device with a 3.0-meter cable, intended for use in clinical settings such as hospitals, intensive care units, or monitoring rooms. It is manufactured without latex and requires cleaning and disinfection between uses. Authorized under FDA 510(k) clearance (K252821), it adheres to traditional review standards and is intended for adult patients (and children over 40 kg) as specified in the submission data.

Frequently asked questions

How is this pulse oximetry sensor different from single-use options, and what does its reusable design mean for clinical workflows?

This sensor is explicitly designed for reuse, unlike single-use alternatives, which means it requires cleaning and disinfection between patients to maintain safety and hygiene. The reusable clip design is ideal for clinical settings like hospitals or intensive care units where frequent monitoring is needed, as it reduces waste and operational costs. The 3-meter cable length also allows flexibility in patient positioning and monitoring locations.

What types of patients is this sensor intended for, and how does the weight restriction apply in practice?

The sensor is intended for adult patients and children weighing over 40 kg, as specified in the regulatory submission. This weight threshold ensures the sensor fits securely on fingers or toes without excessive pressure or discomfort, providing accurate SpO₂ and pulse rate readings. Clinicians should confirm patient weight before use to ensure proper fit and reliability.

What cleaning and disinfection procedures should be followed to maintain the sensor’s performance and safety for reuse?

Since this is a reusable device, it must be cleaned and disinfected between uses to prevent cross-contamination. The manufacturer recommends following standard clinical disinfection protocols for reusable medical devices, though specific instructions should be referenced in the device’s user manual or manufacturer guidelines. Proper cleaning ensures longevity and maintains accuracy in SpO₂ and pulse rate measurements.

Are there different cable lengths available for this sensor, and how might that affect its use in various clinical settings?

Yes, this sensor is available in two cable lengths: 3.0 meters (M1196A) and 0.9 meters (M1196T). The 3-meter version provides greater flexibility for patient mobility and monitoring in larger spaces, such as hospital wards or intensive care units, while the shorter version may be more practical for confined areas like operating rooms or bedside monitoring. The choice depends on the clinical workflow and patient positioning needs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Reusable, adult SpO₂ clip sensor | Pulse oximetry supplies | Philips ..., re-usable GmbH: Mehrweg & Eventservice für Gastronomie, Reusable, adult SpO₂ clip sensor | Pulse oximetry supplies | Philips ..., Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medizin Systeme Böblingen GmbH

Sources (1)

  • FDA 510(k) K252821-1 24 fields · synced Sep 19, 2026