510(k) · Cleared
Recalled · Class II · 2014Sensmart Model X-100 Univeral Oximetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DQA Oximeter
Cleared on Feb 21, 2014 as substantially equivalent to K113215 (Nonin Medical, Inc., 2012) and 4 other predicates after a 204-day review. Its family tree reaches back 12 generations to 1993. 1 of the 86 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 21, 2014
- Review
- 204 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 12 generations to K931154 (1993). 82 ancestors in all, the oldest K850978 (1985). 3 later devices descend from it, 2 citing it directly. 1 of the 86 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations between
- 3 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 2 generations backK102715 Regional OximeterNonin Medical, Inc. · 2010
- 1 generation backK113215 Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012
- This deviceK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter…Nonin Medical, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK233827 OxiWearOxiwear, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK192900 H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 11 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 10 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 9 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 8 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 7 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 6 generations backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- 5 generations backK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- 4 generations backK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- 3 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 2 generations backK102715 Regional OximeterNonin Medical, Inc. · 2010
- 1 generation backK113215 Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012
- This deviceK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014
Class I recalls in this family
- K970209 Capnocheck Plus3 generations back · 1997
Most influential descendants
Showing 3 of 3 · See all- K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc. · 2016 · cites it directly1descendant
- K233827OxiWearOxiwear, Inc. · 2024 · 2 generations on0descendants
- K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −11 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −10 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −9 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −8 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −7 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −6 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| −5 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| −4 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −3 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −2 | K102715 | Regional Oximeter | Nonin Medical, Inc. | 2010 | — |
| −1 | K113215 | Model 7600 Regional Oximeter System with Equanox Technology | Nonin Medical, Inc. | 2012 | — |
| 0 (this device) | K132402 | Sensmart Model X-100 Univeral Oximetry System | Nonin Medical, Inc. | 2014 | — |
| +1 | K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors… | Nonin Medical, Inc. | 2016 | — |
| +2 | K233827 | OxiWear | Oxiwear, Inc. | 2024 | — |
| +1 | K192900 | H500 Multi-Sensing Oximetry System | Nonin Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 1 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113215 | Model 7600 Regional Oximeter System with Equanox TechnologySummary page 1…s SenSmartl Model X-100 Universal Oximetry System is equivalent to the predicate Model 7600 system cleared by the FDA under K113215 on 5/18/2012 including the 80O4CB and 8004CB-NA sensors, the Model 7600 cleared by the FDA under K(102715… | 2012 |
| * | K102715 | Regional OximeterSummary page 9…Model 7600 cleared by the FDA under K113215 on 5/18/2012 including the 8004CB and 8004CB-NA sensors, the Model 7600 cleared by the FDA under K102715 on 12/17/2010 including the 8004CA and 8000CA sensors and Model 7500 Digital Pulse Oximeter and clear… | 2010 |
| * | K080255 | Nonin Medical, Inc., Model 7500 Digital Pulse OximeterSummary page 9…he FDA under K102715 on 12/17/2010 including the 8004CA and 8000CA sensors and Model 7500 Digital Pulse Oximeter and cleared by the FDA under K080255 on 5/23/2008. Nonin's Model 81005(x) reusable soft sensor issubstantially equivalent to Nonin's Mode… | 2008 |
| * | K092101 | Reusable Pulse Oximeter Sensor, Model 8000 SeriesSummary page 1…80005(x) reusable soft sensor cleared by the FDA with Model 7500 Digital Pulse Oximeter under K(080255 on 5/23/2008 and in K092 101 on 10/21/2009. Nonin's SenSmart Download Software is equivalent to Nonin's predicate… | 2009 |
| * | K092678 | Evision Data Management SoftwareSummary page 1…Nonin's SenSmart Download Software is equivalent to Nonin's predicate eVISION Data Management Software cleared by the FDA in K(092678. This software like eVISION isan optional accessory to the SenSmart Model X-100 Uni… | 2009 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2014 | Class II | Z-0901-2015 | Nonconforming Material/Component | Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or… |
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 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 13 of the 82 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K160865 (Nonin Medical, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K113215.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Model X-100 Nonin's SenSmart' Model X-100O Universal Oximetry System isa modular system and is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6)channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. Patient populations include adult, pediatric, infant, and neonate through the use of…
Read the full statement (234 words)
Model X-100
Nonin's SenSmart' Model X-100O Universal Oximetry System isa modular system and is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6)channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. Patient populations include adult, pediatric, infant, and neonate through the use of SenSmart compatible sensors.
The SenSmart system isintended for use in hospitals, long-term care, medical facilities, sleep laboratories, sub-acute environments, and Emergency Medical Services (EMS), including patient transport. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oxlmetry (SpO2) functionality Issuitable for use In both motion and non-motion conditions, Including patients who are well or poorly perfused.
Model 81005(x)
Nonin's Model B100S(X) reusable soft sensor isindicated for non-invasive spot checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, during both motion and non-motion conditions, It Is Intended for use Inenvironments including the operating room, surgical recovery, critical care, emergency room, tong-term care, and mobile environments.
SenSmart Download Software
The SenSmart Download Software isan optional accessory for use with Nonin's X-100M SenSmart Monitor only. It IsIntended for use by healthcare professionals when 1)transferring data from the X-lOOM to a computer Inorder to maintain Individual records of oximetry data, 2)reviewing data according to user-selected parameters, and 3)generating reports.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132402: Sensmart Model X-100 Univeral Oximetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132402
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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