510(k) · Cleared
Recalled · Class II · 2026IQvitals Zone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midmark Corporation · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Nov 17, 2016 as substantially equivalent to K072516 (Midmark Diagnostics Group, 2007) and 4 other predicates after a 128-day review. Its family tree reaches back 14 generations to 1997. 1 of the 68 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Nov 17, 2016
- Review
- 128 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 4
- Predicates
- 5
Its longest line of descent runs back 14 generations to K962603 (1997). 66 ancestors in all, the oldest K853990 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 68 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations between
- 3 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 2 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 1 generation backK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011
- This deviceK161909 IQvitals ZoneMidmark Corporation · 2016
- Descendant · cites it directly · 0 of its ownK253196 Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200…Midmark Corporation · 2026
Show all 14 generations
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 13 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 12 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 11 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 10 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 9 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 8 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 7 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 6 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 5 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 4 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 3 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 2 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 1 generation backK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011
- This deviceK161909 IQvitals ZoneMidmark Corporation · 2016
Class I recalls in this family
- K970209 Capnocheck Plus9 generations back · 1997
Most influential descendants
Showing 1 of 1 · See all- K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −13 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −12 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −11 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −10 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −9 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −8 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −7 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −6 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −5 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −4 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −3 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −2 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −1 | K110028 | Masimo Radical Y Pulse CO-Oximeter | Masimo Corporation | 2011 | — |
| 0 (this device) | K161909 | IQvitals Zone | Midmark Corporation | 2016 | — |
| +1 | K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300… | Midmark Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K072516 | Midmark Diagnostics Iqmark Vital Signs MonitorSummary page 4…Regulation Number 21 CFR 870.2300 Review Panel Cardiovascular 3. Predicate Device Midmark Diagnostics IQmark Vital Signs Monitor (K072516) Vital Signs Monitor VSM 6000 Series; (K101445) Nellcor OxiMax Pulse Oximetry System with N-600x Pulse Oximeter… | 2007 |
| * | K101445 | Vital Signs Monitor-VSM 6000 SeriesSummary page 4…view Panel Cardiovascular 3. Predicate Device Midmark Diagnostics IQmark Vital Signs Monitor (K072516) Vital Signs Monitor VSM 6000 Series; (K101445) Nellcor OxiMax Pulse Oximetry System with N-600x Pulse Oximeter and OxiMax Sensors and Cables (K060576) … | 2010 |
| * | K060576 | Nellcor Oximax N-600X Pulse OximeterSummary page 4… Vital Signs Monitor VSM 6000 Series; (K101445) Nellcor OxiMax Pulse Oximetry System with N-600x Pulse Oximeter and OxiMax Sensors and Cables (K060576) Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028) Exergen TemporalScanner Thermometer (K011291) 4… | 2006 |
| * | K110028 | Masimo Radical Y Pulse CO-OximeterSummary page 4…cor OxiMax Pulse Oximetry System with N-600x Pulse Oximeter and OxiMax Sensors and Cables (K060576) Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028) Exergen TemporalScanner Thermometer (K011291) 4. Device Description… | 2011 |
| * | K011291 | Temporalscanner Thermometer, SensortouchSummary page 4…eter and OxiMax Sensors and Cables (K060576) Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028) Exergen TemporalScanner Thermometer (K011291) 4. Device Description K161909 Page 2 of… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2026 | Class II | Z-3218-2026 | Process change control | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| Aug 21, 2026 | Class II | Z-3217-2026 | Process change control | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| Aug 21, 2026 | Class II | Z-3219-2026 | Process change control | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| Aug 21, 2026 | Class II | Z-3220-2026 | Process change control | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
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 · 9 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 14 of the 66 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K253196 (Midmark Corporation, 2026) has gone furthest, with 0 descendants of its own.
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. 2016, 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 IQvitals Zone is intended to be used by clinicians and medically qualified personnel for measuring and monitoring:
• Noninvasive blood pressure for adult and pediatric patients (3 years and above)
• Pulse rate for adult and pediatric patients
• Noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) for adult and pediatric patients
• Body temperature measured at Temporal Artery for adult and pediatric patients
The most likely location for IQvitals Zone device to be used is for monitoring patient in general medical locations, hospitals and alternative care environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161909 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161909: IQvitals Zone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161909
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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