510(k) · Cleared
ClearedReusable Pulse Oximeter Sensor, Model 8000 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 Oct 21, 2009 as substantially equivalent to K080255 (Nonin Medical, Inc., 2008) and 7 other predicates after a 99-day review. Its family tree reaches back 7 generations to 1991. 1 of the 42 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Oct 21, 2009
- Review
- 99 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 7 generations to K910772 (1991). 34 ancestors in all, the oldest K893221 (1990). 7 later devices descend from it, 2 citing it directly. 1 of the 42 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 2 generations backK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- 1 generation backK040589 Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004
- This deviceK092101 Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK172586 Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter…Nonin Medical, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK241728 Vios Monitoring System (TM) Model 2050; Vios Central Station…Murata Vios, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK233827 OxiWearOxiwear, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970209 Capnocheck Plus2 generations back · 1997
Most influential descendants
Showing 5 of 7 · See all- K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · cites it directly3descendants
- K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · cites it directly2descendants
- K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc. · 2016 · 2 generations on1descendant
- K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc. · 2025 · 2 generations on0descendants
- K233827OxiWearOxiwear, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −6 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −2 | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| −1 | K040589 | Modification to Avant 9600 Pulse Oximeter | Nonin Medical, Inc. | 2004 | — |
| 0 (this device) | K092101 | Reusable Pulse Oximeter Sensor, Model 8000 Series | Nonin Medical, Inc. | 2009 | — |
| +1 | K132402 | Sensmart Model X-100 Univeral Oximetry System | Nonin Medical, Inc. | 2014 | 1 |
| +1 | K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 2018 | 4 |
| +2 | K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors… | Nonin Medical, Inc. | 2016 | — |
| +2 | K241728 | Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios… | Murata Vios, Inc. | 2025 | — |
| +3 | K233827 | OxiWear | Oxiwear, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 1 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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.
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? (8)
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 |
|---|---|---|---|
| * | K080255 | Nonin Medical, Inc., Model 7500 Digital Pulse OximeterSummary page 1…870.2700 Product Code: 74 DQA Predicate Device(s): Nonin's 8000AA sensor as cleared in the following 510(K) submissions: Model 7500 (K080255 cleared on May 23, 2008), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007),… | 2008 |
| * | K063752 | Lifesense, Model LS1-9RSummary page 1…ensor as cleared in the following 510(K) submissions: Model 7500 (K080255 cleared on May 23, 2008), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K040589 cleared on June 3, 2004), Model 4000 (… | 2007 |
| * | K040589 | Modification to Avant 9600 Pulse OximeterSummary page 1…issions: Model 7500 (K080255 cleared on May 23, 2008), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K040589 cleared on June 3, 2004), Model 4000 (K052669 cleared on December 23, 2005), Model 2500A… | 2004 |
| * | K052669 | Avant Digital Pulse Oximetry System, Model 4000, 4100Summary page 1…Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K040589 cleared on June 3, 2004), Model 4000 (K052669 cleared on December 23, 2005), Model 2500A (K050056 cleared on June 21, 2005), Model 2500 (K002690… | 2005 |
| * | K050056 | Model 2500A Palmsat Pulse OximeterSummary page 1…Model 9600 (K040589 cleared on June 3, 2004), Model 4000 (K052669 cleared on December 23, 2005), Model 2500A (K050056 cleared on June 21, 2005), Model 2500 (K002690 cleared on October 11, 2000), Model 2120 (K031487 cleared… | 2005 |
| * | K002690 | Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500Summary page 1…ne 3, 2004), Model 4000 (K052669 cleared on December 23, 2005), Model 2500A (K050056 cleared on June 21, 2005), Model 2500 (K002690 cleared on October 11, 2000), Model 2120 (K031487 cleared on March 22, 2004).… | 2000 |
| * | K031487 | Model Avant 2120 Pulse Oximeter and NibpSummary page 1…er 23, 2005), Model 2500A (K050056 cleared on June 21, 2005), Model 2500 (K002690 cleared on October 11, 2000), Model 2120 (K031487 cleared on March 22, 2004). Envitec's SoftTip Reusable Sensor (Small, Medium and L… | 2004 |
| * | K992215 | Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable…Summary page 1…ared on March 22, 2004). Envitec's SoftTip Reusable Sensor (Small, Medium and Large), cleared under K992215, 29 March 2000. Device Description: The 8000SX is a fingertip transmittance sensor comprised of a mold… | 2000 |
What descends from it? (7)
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 18 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 34 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K132402 (Nonin Medical, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K080255.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Model 8000SX Reusable Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused. 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/K092101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092101: Reusable Pulse Oximeter Sensor, Model 8000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092101
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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