510(k) · Cleared
ClearedH500 Multi-Sensing 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 Jun 29, 2020 as substantially equivalent to K132402 (Nonin Medical, Inc., 2014) after a 258-day review. Its family tree reaches back 13 generations to 1993. 1 of the 84 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 29, 2020
- Review
- 258 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K931154 (1993). 83 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet. 1 of the 84 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations between
- 3 generations backK102715 Regional OximeterNonin Medical, Inc. · 2010
- 2 generations backK113215 Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012
- 1 generation backK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
- This deviceK192900 H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. · 2020
Show all 13 generations
- Root · 13 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 12 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 11 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 10 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 9 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 8 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 7 generations backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- 6 generations backK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- 5 generations backK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- 4 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 3 generations backK102715 Regional OximeterNonin Medical, Inc. · 2010
- 2 generations backK113215 Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012
- 1 generation backK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
- This deviceK192900 H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. · 2020
Class I recalls in this family
- K970209 Capnocheck Plus4 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −12 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −11 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −10 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −9 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −8 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −7 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| −6 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| −5 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −4 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −3 | K102715 | Regional Oximeter | Nonin Medical, Inc. | 2010 | — |
| −2 | K113215 | Model 7600 Regional Oximeter System with Equanox Technology | Nonin Medical, Inc. | 2012 | — |
| −1 | K132402 | Sensmart Model X-100 Univeral Oximetry System | Nonin Medical, Inc. | 2014 | 1 |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K132402 | Sensmart Model X-100 Univeral Oximetry SystemSummary page 4…y MUD, Cardiovascular Predicate Devices Primary Predicate Device - Nonin’s SenSmart X-100 Universal Oximetry System (refer to clearance K132402) is the primary predicate and is a modular system that is indicated for use in simultaneously measuring, displaying, monitoring,… | 2014 |
| † | K160231 | Model X-100C CO-Met™ Oximetry System | 2016 |
| † | K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 14 of the 83 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K132402.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing…
Read the full statement (175 words)
The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.
• For %SpO2 and pulse rate, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients who are well or poorly perfused, during both motion and non-motion conditions in professional healthcare facilities, mobile, and EMS settings.
• For %rSO2, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients in professional healthcare facilities, mobile, and EMS settings.
• For %COHb and %MetHb, the H500 System is intended for spot-checking, multiple spot-checks to observe change, and/or measuring during clinician assessment of adult and pediatric patients in professional healthcare facilities, mobile, and EMS settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192900: H500 Multi-Sensing Oximetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192900
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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