510(k) · Cleared
Recalled · 2007E100 Series SPO2 Sensors
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 Apr 30, 1998 after a 472-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 30, 1998
- Review
- 472 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK970098 E100 Series SPO2 SensorsEpic Medical Equipment Services, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK992211 SPO2 Wrap SensorEpic Medical Equipment Services, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK992092 Stat-Shell Disposable SPO2 SensorEpic Medical Equipment Services, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK990082 Epic SPO2 Finger Sensor, Model E403-09, E412-09 and Epic Oximeter…Epic Medical Equipment Services, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See all- K992211SPO2 Wrap SensorEpic Medical Equipment Services, Inc. · 1999 · cites it directly0descendants
- K992092Stat-Shell Disposable SPO2 SensorEpic Medical Equipment Services, Inc. · 1999 · cites it directly0descendants
- K990082Epic SPO2 Finger Sensor, Model E403-09, E412-09 and Epic Oximeter Cable, Model E710-09Epic Medical Equipment Services, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970098 | E100 Series SPO2 Sensors | Epic Medical Equipment Services, Inc. | 1998 | — |
| +1 | K992211 | SPO2 Wrap Sensor | Epic Medical Equipment Services, Inc. | 1999 | — |
| +1 | K992092 | Stat-Shell Disposable SPO2 Sensor | Epic Medical Equipment Services, Inc. | 1999 | — |
| +1 | K990082 | Epic SPO2 Finger Sensor, Model E403-09, E412-09 and Epic Oximeter Cable, Model… | Epic Medical Equipment Services, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 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? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2007 | Not classified | Z-1188-2008 | Process change control | Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K992211 (Epic Medical Equipment Services, Inc., 1999) has gone furthest, with 0 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?
Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters:
Oximeter Epic M/N
Ohmeda E112-02
Novametrix 500 E192-03
Novametrix Superbright E112-03
Spacelabs oximeter module E112-04
Criticare E112-05
BCI E103-06
Datascope E112-07
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/K970098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970098: E100 Series SPO2 Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970098
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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