Philips Disposable Spo2 Sensors Mii32a And M1133a.
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052377 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)
The Philips Disposable SpO₂ Sensors MII32A and M1133A are single-patient-use, disposable pulse oximetry sensors designed for non-invasive measurement of arterial oxygen saturation (SpO₂) and pulse rate. These sensors adhere to the nomenclature of a pulse oximetry sensor, providing continuous monitoring of oxygenation levels in patients.
These sensors are intended for single-patient use and are manufactured without latex, ensuring compatibility for sensitive patients. They are flexible and can be applied to the hand, foot, or big toe, making them suitable for use on patients weighing less than 3 kg. Supplied sterile and packaged individually, they comply with FDA 510(k) clearance (K052377) and MDR authorisation, ensuring regulatory adherence for clinical use.
Frequently asked questions
Are these pulse oximetry sensors reusable or designed for single-patient use, and why does that matter in a clinical setting?
These sensors are explicitly designed for single-patient use only, as stated in the description. This ensures hygiene and reduces the risk of cross-contamination between patients, which is critical in clinical settings where infection control is paramount. Single-use also eliminates the need for cleaning or sterilization between patients, simplifying workflow and ensuring consistent performance without degradation from reuse.
Can these sensors be used on patients of all sizes, or are there specific weight or age limitations?
The sensors are suitable for patients weighing less than 3 kg, including infants or small children, due to their flexible design and small form factor. They can be applied to the hand, foot, or big toe, making them versatile for pediatric or neonatal monitoring. However, they are not explicitly stated to be suitable for larger patients, so clinical judgment should be used for adults or heavier children.
How are these sensors packaged and stored, and what does the sterile packaging mean for clinical workflow?
The sensors are supplied sterile and packaged individually, which means each unit is ready for immediate clinical use without additional sterilization. This packaging ensures sterility is maintained until first use, reducing the risk of contamination during storage or transport. Clinicians can simply peel open the package and apply the sensor directly to the patient, streamlining the monitoring process.
Are these sensors latex-free, and if so, why is that an important feature for some patients?
Yes, these sensors are manufactured without latex, which is a key feature for patients with latex allergies or sensitivities. Latex allergies can cause severe reactions, including anaphylaxis, so avoiding latex exposure is essential for vulnerable patients. The absence of latex makes these sensors safer for use in clinical settings where allergies are a concern.
What regulatory pathways have these sensors undergone, and how does that affect their clinical use?
These sensors have undergone FDA 510(k) clearance (K052377) and MDR authorization, meaning they meet regulatory standards for safety and effectiveness in the U.S. and European markets. The FDA clearance was determined through an abbreviated review process by the Cardiovascular (CV) Advisory Committee, confirming they are substantially equivalent to legally marketed predecessors. This regulatory backing ensures clinicians can rely on their performance and compliance with global medical device standards.
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: M1133A single-patient wrap sensor |Pulse Oximetry |Philips - Philips, Philips Disposable Spo2 Sensors Mii32a and M1133a., PDF PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A… - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K052377 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (2)
- FDA 510(k) K052377 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026