510(k) · Cleared
ClearedEpic SPO2 Finger Sensor, Model E412-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epic Medical Equipment Services, Inc. · DQA Oximeter
Cleared on Aug 22, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Aug 22, 2000
- Review
- 29 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK002223 Epic SPO2 Finger Sensor, Model E412-20Epic Medical Equipment Services, Inc. · 2000
- 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 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · 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) | K002223 | Epic SPO2 Finger Sensor, Model E412-20 | Epic Medical Equipment Services, Inc. | 2000 | — |
| +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 |
| 2009 | 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), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 182 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?
- 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 | — |
https://510kreport.com/device/K002223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002223: Epic SPO2 Finger Sensor, Model E412-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002223
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026