510(k) · Cleared
ClearedShenzhen Med-Linket Adult Finger Clip SPO2 Sensor, Shenzhen Med-Linket Adult Silicone Soft Tip SPO2 Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Med-Link Electronics Tech Co., Ltd. · DQA Oximeter
Cleared on Jun 10, 2009 after a 244-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Jun 10, 2009
- Review
- 244 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K910852 | FDA’s K910852 is 507 Non-Invasive Vital Signs Monitor 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…Predicate Equivalent Devices: Model 510(k) Number Manufacturer/ Model Adult Silicone Soft Tip K910852* CSI 975AD-3 Adult SpO2 Sensor, Model Reusable Pita SpO2… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083010 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083010: Shenzhen Med-Linket Adult Finger Clip SPO2 Sensor, Shenzhen Med-Linket Adult Silicone Soft Tip SPO2 Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083010
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026