510(k) · Cleared
ClearedMouthLab Vital Signs Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Multisensor Diagnostics (Dba Aidar Health) · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 6, 2021 as substantially equivalent to K150869 (Viatom Technology Co., Ltd., 2015) and 2 other predicates after a 235-day review. Its family tree reaches back 18 generations to 1997. 1 of the 189 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 6, 2021
- Review
- 235 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K962603 (1997). 188 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet. 1 of the 189 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 14 generations between
- 3 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 2 generations backK132808 Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc. · 2013
- 1 generation backK171621 Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex…Welch Allyn, Inc. · 2017 · Recalled
- This deviceK201635 MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021
Show all 18 generations
- Root · 18 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 17 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 16 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 15 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 14 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 13 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 12 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 11 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 10 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 9 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 8 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 7 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 6 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 5 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 4 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 3 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 2 generations backK132808 Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc. · 2013
- 1 generation backK171621 Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex…Welch Allyn, Inc. · 2017 · Recalled
- This deviceK201635 MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021
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 |
|---|---|---|---|---|---|
| −18 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −17 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −16 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −15 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −14 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −13 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −12 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −11 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −10 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −9 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −8 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −7 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −6 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −5 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −4 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −3 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −2 | K132808 | Vital Signs Monitor, Connex Vital Signs Monitor | Welch Allyn, Inc. | 2013 | — |
| −1 | K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall… | Welch Allyn, Inc. | 2017 | 3 |
| 0 (this device) | K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 6 | 0 |
| 1994 | 8 | 0 |
| 1995 | 11 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 1 |
| 1998 | 10 | 0 |
| 1999 | 14 | 0 |
| 2000 | 19 | 0 |
| 2001 | 5 | 0 |
| 2002 | 14 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 5 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K150869 | Checkme Pro Health MonitorSummary page 4…r Primary Product Code: MWI Secondary Product DQA, DPS, FLL, BZQ, DXN, BZH Codes: Predicate Devices: Primary: CheckMe Pro Health Monitor (K150869) Secondary: Connex Vital Signs 6000 Monitor (K171621) Wing S… | 2015 |
| * | K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Summary page 4…ZQ, DXN, BZH Codes: Predicate Devices: Primary: CheckMe Pro Health Monitor (K150869) Secondary: Connex Vital Signs 6000 Monitor (K171621) Wing Smart FEV1 and Peak Flow Meter (K152276) R… | 2017 |
| * | K152276 | Wing Smart FEVI and Peak Flow MeterSummary page 4…Secondary: Connex Vital Signs 6000 Monitor (K171621) Wing Smart FEV1 and Peak Flow Meter (K152276) Reference Devices: Masimo Acoustic Respiration Sensor (K120984) ReadMyHear… | 2016 |
| † | K120984 | Masimo Ras-125C Acoustic Respiration Sensor | 2013 |
| † | K050620 | Readmyheart, Model RMH3.0 | 2005 |
| † | K180487 | Peak.me | 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 24 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 27 of the 188 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K150869.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The MouthLab Vital Signs Monitoring System is a hand-held, wireless device intended to record, transfer, store and display single lead electrocardiography (ECG), heart rate (HR), heart rate variability (HRV), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), respiration pattern (RP), oral temperature (TEMP) and basic lung function measurements: peak expiratory flow (PEF) and forced expiratory volume in…
Read the full statement (181 words)
The MouthLab Vital Signs Monitoring System is a hand-held, wireless device intended to record, transfer, store and display single lead electrocardiography (ECG), heart rate (HR), heart rate variability (HRV), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), respiration pattern (RP), oral temperature (TEMP) and basic lung function measurements: peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1).
This system is for spot checking and does not have continuous monitoring capability or any alarm features. The device comes in contact with the user for approximately 60 seconds at each use and the captured medical parameters shall be displayed on a mobile application.
It is intended for use by adults in the home environment and in healthcare facilities. This system makes no specific diagnosis. Respiration rate is not intended for adults with underlying or suspected medical conditions. The device is for single user use.
It is intended for use with users who are well perfused and during no motion condition. Users with implanted pacemakers and/or implanted cardioverter-defibrillators (ICDs) are not recommended to use the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201635: MouthLab Vital Signs Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201635
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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