510(k) · Cleared
ClearedDX Series Finger Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dixtal Medical, Inc. · DQA Oximeter
Cleared on Mar 8, 2010 as substantially equivalent to K993979 (Novametrix Medical Systems, Inc., 2000) and 1 other predicate after a 62-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Mar 8, 2010
- Review
- 62 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962603 (1997). 8 ancestors in all, the oldest K913516 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 2 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 1 generation backK993979 MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 2000 · Recalled
- This deviceK100020 DX Series Finger SensorDixtal Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −2 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −1 | K993979 | MARSPO2, Model 2001 | Novametrix Medical Systems, Inc. | 2000 | 1 |
| 0 (this device) | K100020 | DX Series Finger Sensor | Dixtal Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 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? (4)
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 |
|---|---|---|---|
| * | K993979 | MARSPO2, Model 2001Summary page 1…QA Legally Marketed Predicate Devices Legally marketed predicate devices to the DX Series Sensors: * Novametrix 8776-00 Finger and 8791-00 Wrap (Y)Sensor (K993979) * Novametrix' Marquette Compatible 9752-00 Finger and 9753-00 Wrap (Y) Sensor (K(010451) a Nellcor DS100A Adul… | 2000 |
| * | K010451 | Novametrix Marquette Compatible SensorsSummary page 1…ors: * Novametrix 8776-00 Finger and 8791-00 Wrap (Y)Sensor (K993979) * Novametrix' Marquette Compatible 9752-00 Finger and 9753-00 Wrap (Y) Sensor (K(010451) a Nellcor DS100A Adult Finger Clip Sensor and D-YS Multisite Sensor * Philips M1196A Adult SP02 Clip Sensor, M… | 2001 |
| * | — | Nellcor DS100A Adult Finger Clip Sensor and D-YS Multisite Sensor Named without a submission number | |
| * | — | Philips M1196A Adult SpO2 Clip Sensor, M1191A Soft Glove Sensor (series) and M1194A Ear… Named without a submission number |
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.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 2 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K993979.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
DX Series Pulse Oximeter Sensors are multi-patient-use sensors intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, infant, pediatric and adult patients, in environments where pulse oximetry monitors or modules in multi-parameter systems are indicated for use, when in the judgment of a licensed medical practitioner/physician pulse oximetry is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100020 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100020: DX Series Finger Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100020
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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