Unimed Medical Supplies, Inc. · Class II · Cleared Feb 6, 2025
| K-number | K242580 |
| Device name | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) |
| Applicant | Unimed Medical Supplies, Inc. |
| Product code | DQA |
| Device class | Class II |
| Decision date | Feb 6, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.2700 |
The Unimed Reusable Finger Clip SpO2 Sensors are non-invasive pulse oximetry sensors that continuously monitor oxygen saturation (SpO2) and pulse rate in adult patients weighing >30 kg and pediatric patients weighing 10–50 kg. They are reusable finger-clip sensors compatible with Masimo Radical-7 monitors and are for prescription use only.
The subject devices use two-wavelength relative optical absorption (660 nm/905 nm LEDs) with a photodetector, cable, connector, and silicone finger-clip housing. Key changes from the predicate include a faster-responding photodetector, smaller finger-clip sizing for pediatric use (U103-125), and different connector types (M8 vs M10) to expand monitor compatibility, while maintaining identical material composition, SpO2 accuracy (±3%), and pulse rate accuracy (±3 bpm).
IEC 60601-1:2005 (electrical safety), IEC 60601-1-2:2014+AMD1:2020 (EMC), ISO 80601-2-61:2017 (pulse oximeter requirements), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (skin irritation). Clinical validation per ISO 80601-2-61 and FDA guidance via hypoxia testing in adult volunteers with darkly pigmented subjects.
The devices maintain identical operating principles, materials, performance specifications (SpO2 ±3%, PR ±3 bpm), environmental tolerances, and biocompatibility to the predicate device K142832. Although the subject submission narrows the patient population (removing neonates <3 kg and adults 30–40 kg), restricts to finger-only sites, and covers only reusable variants, these changes represent a subset of the predicate's intended use rather than expansion into new risk domains. The photodetector and connector modifications do not alter fundamental safety or effectiveness; clinical testing confirms accuracy equivalence. Therefore, the same intended function and principle of operation, supported by equivalent test data, establishes substantial equivalence.
View the full FDA submission: accessdata.fda.gov