# K251696: Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Medical Supplies, Inc.
- Decided: Dec 1, 2025 after 182 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K941811 (1994). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142832: Unimed Disposable and Reusable SPO2 Sensors, Unimed Medical Supplies, Inc. (2015) Summary page 5.

## Indications for use
Unimed Reusable SpO₂ Sensors (U410-48 and U410-29) (U410-48); Unimed Reusable SpO₂ Sensors (U410-48 and U410-29) (U410-29) Unimed Reusable SpO₂ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused, when applied to the finger. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.

Source page: https://510kreport.com/device/K251696
Methodology: https://510kreport.com/methodology