510(k) · Cleared
ClearedSolaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solaris Medical Technology, Inc. · DQA Oximeter
Cleared on Jul 25, 2008 as substantially equivalent to K001688 (Datex-Ohmeda, Inc., 2000) after a 249-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jul 25, 2008
- Review
- 249 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001688 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001688 Datex-Ohmeda Tuffsat 3000 Pulse OximeterDatex-Ohmeda, Inc. · 2000
- This deviceK073249 Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesSolaris Medical Technology, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK123797 NT1D Vital Signs MonitorNew Tech, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK092950 Solaris Models NT1 and NT1A Handheld Pulse Oximeters with Sensor…Solaris Medical Technology, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001688 | Datex-Ohmeda Tuffsat 3000 Pulse Oximeter | Datex-Ohmeda, Inc. | 2000 | — |
| 0 (this device) | K073249 | Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories | Solaris Medical Technology, Inc. | 2008 | — |
| +1 | K123797 | NT1D Vital Signs Monitor | New Tech, Inc. | 2013 | — |
| +1 | K092950 | Solaris Models NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories | Solaris Medical Technology, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K001688 | Datex-Ohmeda Tuffsat 3000 Pulse OximeterSummary page 4…sories demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate device, the Datex-Ohmeda TufSet 3000 Pulse Oximeter, K001688. Page 4 of 4 DEPARTMENT OF HEALTH & HUMAN… | 2000 |
What descends from it? (2)
2 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?
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?
Solaris NT1 and NT1A Handheld Pulse Oximeters with sensor accessories are non-invasive spot-check, oxygen saturation and pulse rate monitors. They operate on battery power using SOLARIS reusable Sp02 sensors for pediatric and adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073249: Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073249
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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