Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)
by Unimed Medical Supplies, Inc.
510(k) K250931
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK250931 | Date13 Aug 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DQA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Unimed Reusable SpO₂ Sensors are classified as pulse oximeter sensors under the FDA’s DQA product code. These devices measure oxygen saturation (SpO₂) in arterial blood by detecting light absorption through peripheral tissue, providing real-time noninvasive monitoring of oxygen levels. They are designed for repeated clinical use in settings such as hospitals, clinics, and patient monitoring environments.
These sensors are reusable and supplied in sterile packaging for single-use before sterilisation. They are intended for use with compatible pulse oximeters and comply with FDA 510(k) clearance and EU MDR requirements. The series includes two models (-117 and -121) with distinct reference codes (U403-117, U103-117, U410-121, U110-121), each requiring proper sterilisation between uses. No MRI safety or size specifications are noted in the regulatory data.
Other devices from Unimed Medical Supplies, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these sensors designed for single-use or repeated clinical use, and how should they be prepared for reuse?
These sensors are reusable but are supplied in sterile packaging for single-use before sterilization. After each use, they must undergo proper sterilization to ensure safety and hygiene for repeated clinical use in hospitals, clinics, or patient monitoring environments. The manufacturer does not specify sterilization methods, so follow your facility’s validated protocols.
What types of pulse oximeters are compatible with these Unimed SpO₂ sensors?
The sensors are designed for use with compatible pulse oximeters, though the exact models are not listed in the regulatory data. Compatibility depends on the sensor’s physical and electrical interface (e.g., connector type, signal transmission). Always verify compatibility with your oximeter’s manufacturer before use to ensure accurate SpO₂ readings.
How do I determine which model (-117 or -121 series) is right for my facility?
The two series (-117 and -121) differ by reference codes (U403-117, U103-117, U410-121, U110-121), but the regulatory data does not specify functional or size-based distinctions between them. Selection should be based on compatibility with your pulse oximeter’s sensor interface and your facility’s preferred sterilization workflow. Contact Unimed Medical Supplies for clarification if unsure.
What regulatory pathways have these sensors undergone, and what does that mean for my facility?
These sensors are cleared under FDA’s 510(k) pathway (K250931) and comply with EU MDR requirements, indicating they meet U.S. and European safety/performance standards for pulse oximeter sensors. The clearance is based on substantial equivalence to predicate devices, meaning they share similar intended use (noninvasive SpO₂ monitoring) and risk profiles. Your facility can use them if they align with your hospital’s procurement and infection control policies.
Are there any special storage requirements for these reusable sensors before or after sterilization?
The regulatory data does not specify storage conditions, but reusable medical devices generally require clean, dry, and protected environments to prevent contamination. After sterilization, store sensors in a dedicated, labeled case or packaging away from direct light, moisture, or chemical exposure. Follow your facility’s sterile storage protocols to maintain integrity until use.