510(k) · Cleared
Recalled · Class II · 2020V10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediana Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 15, 2017 as substantially equivalent to K152659 (Mediana Co., Ltd., 2016) after a 301-day review. Its family tree reaches back 14 generations to 1997. 3 of the 110 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 15, 2017
- Review
- 301 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 14 generations to K962603 (1997). 108 ancestors in all, the oldest K863784 (1986). 1 later device descends from it, 1 citing it directly. 3 of the 110 devices in this family, counting this one, have 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 backK130320 Bedside Respiratory Patient Monitoring System, Bedside Respiratory…Covidien · 2014
- 2 generations backK142865 Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC · 2015 · Recalled
- 1 generation backK152659 V10Mediana Co., Ltd. · 2016
- This deviceK170497 V10Mediana Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
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 backK051896 Model 750E Series MonitorCas Medical Systems, Inc. · 2005
- 5 generations backK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
- 4 generations backK121806 Beside Respiratory Patient Monitoring System Beside Resiratory…Covidien · 2012
- 3 generations backK130320 Bedside Respiratory Patient Monitoring System, Bedside Respiratory…Covidien · 2014
- 2 generations backK142865 Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC · 2015 · Recalled
- 1 generation backK152659 V10Mediana Co., Ltd. · 2016
- This deviceK170497 V10Mediana Co., Ltd. · 2017
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K200434V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · 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 | K051896 | Model 750E Series Monitor | Cas Medical Systems, Inc. | 2005 | — |
| −5 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | — |
| −4 | K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient… | Covidien | 2012 | — |
| −3 | K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient… | Covidien | 2014 | — |
| −2 | K142865 | Nellcor Bedside SpO2 Patient Monitoring System | Covidien, LLC | 2015 | 1 |
| −1 | K152659 | V10 | Mediana Co., Ltd. | 2016 | — |
| 0 (this device) | K170497 | V10 | Mediana Co., Ltd. | 2017 | — |
| +1 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 8 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 1 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 4 | 0 |
| 2002 | 8 | 1 |
| 2003 | 5 | 0 |
| 2004 | 4 | 1 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
3 devices in this family have 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K152659 | V10Summary page 4…Predicate Devices (Legally Marketed Devices) The predicate device for the V10 are: Mediana Co., Ltd. Vital Signs Monitors, V10 Cleared by FDA through 510(k) No. K152659 Device Description The V10 vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional o… | 2016 |
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 |
|---|---|---|---|
| K200434 | V20, V20a, AVSM3 SNF | 2020 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2020 | Class II | Z-2441-2020 | Process change control | Failures were found in the temperature measurement function while in the predict mode. |
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.
- K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 13 Class I recalls
- K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & AccessoriesDatex-Ohmeda, Inc. · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- 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 20 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 23 of the 108 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K200434 (Mediana Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO₂), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.…
Read the full statement (213 words)
The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO₂), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.
Note: Hospital use typically includes such as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.
Note: The medically skilled and trained user can be clinicians like doctors and nurses who know how to take and interpret a patient’s vital signs. These clinicians must take direct responsibility for the patient’s life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient’s life. This equipment should only be operated by trained users who can adjust the settings of the vital signs monitor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170497: V10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170497
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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