510(k) · Cleared
ClearedReusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips Adult Soft Tip Sensor (U403S-91)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimed Medical Supplies, Inc. · DQA Oximeter
Cleared on Dec 2, 2008 as substantially equivalent to K053420 (Tenacore Holdings, Inc., 2006) after a 90-day review. Its family tree reaches back 2 generations to 1998. 15 later devices descend from it.
- Decided
- Dec 2, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973970 (1998). 3 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973970 SPO2 Finger ProbesMedical Cables, Inc. · 1998
- 1 generation backK053420 Tenacore SP02 SensorsTenacore Holdings, Inc. · 2006
- This deviceK082546 Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger…Unimed Medical Supplies, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK242580 Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable…Unimed Medical Supplies, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK202851 Spo2 SensorJkh USA, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK201360 Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK191279 Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd. · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015 · cites it directly14descendants
- K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc. · 2025 · 2 generations on1descendant
- K202851Spo2 SensorJkh USA, LLC · 2020 · cites it directly1descendant
- K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd. · 2020 · 2 generations on1descendant
- K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973970 | SPO2 Finger Probes | Medical Cables, Inc. | 1998 | — |
| −1 | K053420 | Tenacore SP02 Sensors | Tenacore Holdings, Inc. | 2006 | — |
| 0 (this device) | K082546 | Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip… | Unimed Medical Supplies, Inc. | 2008 | — |
| +1 | K142832 | Unimed Disposable and Reusable SPO2 Sensors | Unimed Medical Supplies, Inc. | 2015 | — |
| +2 | K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger… | Unimed Medical Supplies, Inc. | 2025 | — |
| +1 | K202851 | Spo2 Sensor | Jkh USA, LLC | 2020 | — |
| +2 | K201360 | Reusable and Disposable SpO2 Sensors | Xinkang Medical Instrument Co., Ltd. | 2020 | — |
| +2 | K191279 | Disposable SpO2 Sensor | Shenzhen Caremed Medical Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053420 | Tenacore SP02 SensorsSummary page 1…Predicate 510(K) Predicate Manufacturer/Models U4XX Series K053420 Tenacore Holdings, Inc. Adult Finger Cli… | 2006 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K142832 (Unimed Medical Supplies, Inc., 2015) has gone furthest, with 14 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. 2008, 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 SpO2 finger sensors are indicated for use to measure the approximate, non-invasive
and continuous arterial oxygen saturation and pulse rate of patients weighting more
than 40kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082546: Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips Adult Soft Tip Sensor (U403S-91).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082546
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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