510(k) · Cleared
ClearedSPO2 Finger Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Cables, Inc. · DQA Oximeter
Cleared on Oct 6, 1998 after a 354-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.
- Decided
- Oct 6, 1998
- Review
- 354 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 1 citing it directly.
- This deviceK973970 SPO2 Finger ProbesMedical Cables, Inc. · 1998
- Descendant · cites it directly · 16 of its ownK053420 Tenacore SP02 SensorsTenacore Holdings, Inc. · 2006
- Descendant · 2 generations on · 15 of its ownK082546 Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger…Unimed Medical Supplies, Inc. · 2008
- Descendant · 3 generations on · 14 of its ownK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
- Descendant · 4 generations on · 1 of its ownK242580 Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable…Unimed Medical Supplies, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK202851 Spo2 SensorJkh USA, LLC · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K053420Tenacore SP02 SensorsTenacore Holdings, Inc. · 2006 · cites it directly16descendants
- K082546Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips…Unimed Medical Supplies, Inc. · 2008 · 2 generations on15descendants
- K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015 · 3 generations on14descendants
- K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc. · 2025 · 4 generations on1descendant
- K202851Spo2 SensorJkh USA, LLC · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973970 | SPO2 Finger Probes | Medical Cables, Inc. | 1998 | — |
| +1 | K053420 | Tenacore SP02 Sensors | Tenacore Holdings, Inc. | 2006 | — |
| +2 | K082546 | Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip… | Unimed Medical Supplies, Inc. | 2008 | — |
| +3 | K142832 | Unimed Disposable and Reusable SPO2 Sensors | Unimed Medical Supplies, Inc. | 2015 | — |
| +4 | K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger… | Unimed Medical Supplies, Inc. | 2025 | — |
| +3 | K202851 | Spo2 Sensor | Jkh USA, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053420 | Tenacore SP02 Sensors | 2006 | 16 |
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.
What does this lineage say?
- Of its descendants, K053420 (Tenacore Holdings, Inc., 2006) has gone furthest, with 16 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 compatible Medical Cables, Inc. SpO₂ Finger Probe has the same intended use as the predicate probes, i.e. recommended for use in short term continuous noninvasive SpO₂ saturation and pulse rate monitoring on patients weighing greater than 40kg. The intended environment of use of the Medical Cables SpO₂ Finger Probe is the same as the predicate probe, i.e. in a medical or clinical environment under the direction of a physician.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973970: SPO2 Finger Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973970
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026