# K083010: Shenzhen Med-Linket Adult Finger Clip SPO2 Sensor, Shenzhen Med-Linket Adult Silicone Soft Tip SPO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Jun 10, 2009 after 244 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K910852: 507 Non-Invasive Vital Signs Monitor, Criticare Systems, Inc. (1991). Our reading of the summary gave K910852, FDA’s number for 507 Non-Invasive Vital Signs Monitor (Criticare Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CSI 975AD-3 Adult Reusable Pita SpO2 Sensor, 3 foot”. Kept off the family tree. Summary page 2.

## Indications for use
The Shenzhen Med-LinketTM Adult SpO2 Finger Sensor is indicated for use in continuous, non-invasive arterial oxygen saturation and pulse rate monitoring. Model S0044D-S (S0012A) is reusable and for patients weighing more than 40 kg. The Shenzhen Med-Linket TM Adult SpO2 Finger Sensor is contraindicated for use on active patients, or during conditions of motion or low perfusion.

Source page: https://510kreport.com/device/K083010
Methodology: https://510kreport.com/methodology