510(k) · Cleared
ClearedSolaris Models 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 Mar 12, 2010 as substantially equivalent to K073249 (Solaris Medical Technology, Inc., 2008) after a 169-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Mar 12, 2010
- Review
- 169 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001688 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK001688 Datex-Ohmeda Tuffsat 3000 Pulse OximeterDatex-Ohmeda, Inc. · 2000
- 1 generation backK073249 Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesSolaris Medical Technology, Inc. · 2008
- This deviceK092950 Solaris Models NT1 and NT1A Handheld Pulse Oximeters with Sensor…Solaris Medical Technology, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001688 | Datex-Ohmeda Tuffsat 3000 Pulse Oximeter | Datex-Ohmeda, Inc. | 2000 | — |
| −1 | K073249 | Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories | Solaris Medical Technology, Inc. | 2008 | — |
| 0 (this device) | K092950 | Solaris Models NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories | Solaris Medical Technology, Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K073249 | Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesSummary page 2…Pag-e I of 3 5. Common or Usual Name: Oximeter. Pulse 74 OQA. 21 CFR Part 870.2700 6. Predicate Device Information: K073249, SOLARIS INT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories, Solaris Medical Technology, Inc. 7. Device Descri… | 2008 |
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 10 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K073249.
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?
The Solaris NT1 Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check, functional arterial oxygen saturation and pulse rate monitor. The device operates on battery power using SOLARIS reusable SpO2 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff. The Solaris NT1A Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check or…
Read the full statement (124 words)
The Solaris NT1 Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check, functional arterial oxygen saturation and pulse rate monitor. The device operates on battery power using SOLARIS reusable SpO2 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.
The Solaris NT1A Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check or continuous monitoring, functional arterial oxygen saturation and pulse rate monitor. The device has data storage and data transfer functionality via a USB hub. The device operates on battery power using SOLARIS reusable SpO2 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092950: Solaris Models 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 4, 2026. https://510kreport.com/device/K092950
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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