Unimed Reusable SpO2 Sensors - Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K251693 ↗

FDA Product Code

DQA

Models / Variants

Unimed Reusable SpO2 Sensors (-75 Series) (U410-75)

Unimed Reusable SpO2 Sensors (-75 Series) (U110-75)

Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75)

Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75)

Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Disposable ECG Lead Wire

  Class I

  CE/MDR

• Unimed D6-RT180D-I

  Class II

  GUDID on market

• Unimed D33-16161-I

  Class II

  GUDID on market

• Temperature probes (T2252-PG)

  Class II

  FDA 510(k) K253162 Active Cleared 5 Jun 2026

• Disposable NIBP Cuff

  Class I

  CE/MDR

• Invasive BP Adaptor Cable

  Class I

  CE/MDR

See all devices from Unimed Medical Supplies, Inc. →

• Are these sensors meant for single-use or can they be reused in clinical settings?

  These sensors are explicitly designed for reusable clinical use in hospitals, home healthcare, or ambulatory settings. The ‘-75 Series’ designation confirms their intended reuse, though proper cleaning and maintenance per manufacturer instructions are required to ensure performance and sterility between uses. The ‘S’ suffix variants (e.g., U410S-75) indicate they are supplied sterile, while non-‘S’ models (e.g., U410-75) are non-sterile and must be sterilized before reuse.

• How do the different model numbers (e.g., U410-75 vs. U110S-75) differ, and which one should I choose for my patients?

  The models vary primarily in sensor size or attachment mechanism, though exact specifications (e.g., finger size compatibility) are detailed in the manufacturer’s documentation. The ‘S’ suffix denotes sterile packaging, which may be critical for sterile procedures or high-risk patients. For example, the U110S-75 is sterile, while the U110-75 is not. Consult the manufacturer’s guidelines to select the appropriate size and sterility level for your patient population.

• What storage requirements should I follow to ensure these sensors remain functional and accurate over time?

  The manufacturer’s instructions outline specific storage conditions to maintain performance, though these details are not provided in the data. Generally, reusable medical devices like these require protection from moisture, extreme temperatures, and contamination. Since they are reusable, proper cleaning and storage per guidelines are essential to prevent degradation of the photoplethysmographic technology used for SpO₂ readings.

• What regulatory pathways have these sensors undergone, and how does that affect their use in my facility?

  These sensors are authorized under FDA 510(k) clearance (K251693) and comply with MDR (Medical Device Regulation) standards. The clearance confirms they are substantially equivalent to a predicate device and fall under the Cardiovascular advisory committee (CV) classification. This means they meet FDA’s requirements for safety and effectiveness as a noninvasive pulse oximeter, but your facility must adhere to local policies for reusable devices, including sterilization and maintenance protocols.

• Can these sensors be used for continuous monitoring in home healthcare settings, and what considerations should I keep in mind?

  Yes, these sensors are intended for use in home healthcare alongside hospital and ambulatory settings, as they are designed for reusable, continuous monitoring of SpO₂ via photoplethysmography. For home use, ensure the selected model (e.g., U210S-75) aligns with patient needs—such as finger size—and follow manufacturer instructions for sterilization (if reusable) and storage to maintain accuracy. Since they are reusable, proper hygiene practices are critical to prevent cross-contamination.