510(k) · Cleared
ClearedSingle-Patient Use Disposable Sensor Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DQA Oximeter
Cleared on Jun 4, 2010 as substantially equivalent to K063752 (Nonin Medical, Inc., 2007) and 3 other predicates after a 170-day review. Its family tree reaches back 4 generations to 1995. 1 of the 12 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jun 4, 2010
- Review
- 170 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K950387 (1995). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK950387 GeminiSpegas Industries, Ltd. · 1995
- 3 generations backK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
- 2 generations backK024300 Microcap Plus/NPB-75Oridion Medical 1987, Ltd. · 2003
- 1 generation backK063752 Lifesense, Model LS1-9RNonin Medical, Inc. · 2007
- This deviceK093853 Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK103685 Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN…Beijing Rongrui-Century Scie. & Tech. Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK103584 Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda…Shenzhen Envisen Industry Co. Limited · 2011
Class I recalls in this family
- K970209 Capnocheck Plus2 generations back · 1997
Most influential descendants
Showing 2 of 2 · See all- K103685Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI…Beijing Rongrui-Century Scie. & Tech. Co., Ltd. · 2011 · cites it directly0descendants
- K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950387 | Gemini | Spegas Industries, Ltd. | 1995 | — |
| −3 | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | Spegas Industries, Ltd. | 1997 | — |
| −2 | K024300 | Microcap Plus/NPB-75 | Oridion Medical 1987, Ltd. | 2003 | — |
| −1 | K063752 | Lifesense, Model LS1-9R | Nonin Medical, Inc. | 2007 | — |
| 0 (this device) | K093853 | Single-Patient Use Disposable Sensor Series | Nonin Medical, Inc. | 2010 | — |
| +1 | K103685 | Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA… | Beijing Rongrui-Century Scie. & Tech. Co., Ltd. | 2011 | — |
| +1 | K103584 | Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible… | Shenzhen Envisen Industry Co. Limited | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 1 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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.
1 device in this family has a Class I recall. 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K071128 | FDA’s K071128 is Scanscope XT System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
| * | K063752 | Lifesense, Model LS1-9RSummary page 1…ensor as cleared in the following 510(K) submissions: Model 7500 (K07128 cleared on July 12, 2007), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K023044 cleared on July 23, 2003), Model 2500A… | 2007 |
| * | K023044 | Model 9600, Avant Pulse OximeterSummary page 1…issions: Model 7500 (K07128 cleared on July 12, 2007), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K023044 cleared on July 23, 2003), Model 2500A (K050056 cleared on June 21, 2005), and Model 2500… | 2003 |
| * | K050056 | Model 2500A Palmsat Pulse OximeterSummary page 1…Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K023044 cleared on July 23, 2003), Model 2500A (K050056 cleared on June 21, 2005), and Model 2500 (K002690 cleared on October 11, 2000). Device Description: T… | 2005 |
| * | K002690 | Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500Summary page 1…Model 9600 (K023044 cleared on July 23, 2003), Model 2500A (K050056 cleared on June 21, 2005), and Model 2500 (K002690 cleared on October 11, 2000). Device Description: The 6OOOCX are single-patient use disposable, cloth… | 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? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K103685 (Beijing Rongrui-Century Scie. & Tech. Co., Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063752.
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?
Nonin's Models 6000CA and 7000A Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments. Nonin's Models 6000CP and…
Read the full statement (242 words)
Nonin's Models 6000CA and 7000A Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.
Nonin's Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of pediatric patients who are well or poorly perfused, weighing greater than 22 pounds (>10 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.
Nonin's Models 6000CI and 70001 Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of infant patients who are well or poorly perfused, weighing greater than 4 pounds (>2 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.
Nonin's Models 6000CN and 7000N Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of neonate/adult patients who are well or poorly perfused, weighing less than 4 pounds (<2 kilograms) or adults weighing greater than 66 pounds (>30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093853: Single-Patient Use Disposable Sensor Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093853
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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