510(k) · Cleared
ClearedPatient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediana Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Nov 9, 2011 as substantially equivalent to K082812 (Omron Healthcare, Inc., 2008) and 3 other predicates after a 103-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Nov 9, 2011
- Review
- 103 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K962603 (1997). 63 ancestors in all, the oldest K872291 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 2 generations backK062095 Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2006
- 1 generation backK100217 Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd. · 2010
- This deviceK112190 Patient MonitorMediana Co., Ltd. · 2011
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 4 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 3 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 2 generations backK062095 Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2006
- 1 generation backK100217 Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd. · 2010
- This deviceK112190 Patient MonitorMediana Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −4 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −3 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −2 | K062095 | Mcare 300 Vital Signs Monitor, Model 91220 | Spacelabs Medical, Inc. | 2006 | — |
| −1 | K100217 | Lucon M-Series Patient Monitor, Models M20 and M30 | Mediana Co., Ltd. | 2010 | — |
| 0 (this device) | K112190 | Patient Monitor | Mediana Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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.
Planning a device in MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K082812 | Omron Model HBP-2070 Vital Signs MonitorSummary page 1…predicate devices for Patient monitors, Model YM6000 are: * Omron Healthcare Inc. Omron Model HBP-2070 Vital Signs Monitor cleared by FDA through 510(k) No. K(082812, Spacolabs Medical Inc. mCare 300 Vital Signs Monitors, Model 91220 cleared by FDA through 51 0(k) No. K(062095,… | 2008 |
| * | K062095 | Mcare 300 Vital Signs Monitor, Model 91220Summary page 1…tor cleared by FDA through 510(k) No. K(082812, Spacolabs Medical Inc. mCare 300 Vital Signs Monitors, Model 91220 cleared by FDA through 51 0(k) No. K(062095, *Omron Healthcare Inc. Colin Press Mate Model BP-5510 cleared by FDA through 51 0(k) No. K(063690, Mediana Co.,… | 2006 |
| * | K063690 | Colin Press Mate, Model BP S510Summary page 1…tors, Model 91220 cleared by FDA through 51 0(k) No. K(062095, *Omron Healthcare Inc. Colin Press Mate Model BP-5510 cleared by FDA through 51 0(k) No. K(063690, Mediana Co., Ltd. Lucon M-Series Patient Monitor, Model M20 and M30 cleared by FDA through 510(k) No. K100217… | 2007 |
| * | K100217 | Lucon M-Series Patient Monitor, Models M20 and M30Summary page 1…5510 cleared by FDA through 51 0(k) No. K(063690, Mediana Co., Ltd. Lucon M-Series Patient Monitor, Model M20 and M30 cleared by FDA through 510(k) No. K100217 21… | 2010 |
| † | K042601 | Capnostat 5 | 2004 |
| † | K053174 | Loflo C5 CO2 Sensor | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 63 ancestors have a recall of any class.
- 2 other devices also cite its predicate K082812.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO 2 and InCa 2) and temperature for adult, pediatric and neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a…
Read the full statement (221 words)
The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO 2 and InCa 2) and temperature for adult, pediatric and neonate 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.
Note: Hospital use typically includes such areas 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, surgicenters, and sub-acute centers.
Note: The medically skilled and trained user can be any clinicians like doctor and nurse who know how to take and interpret a patient's vital signs. These clinicians must take the direct responsibility for patient life. It can include a care-giver or medically trained intern reter who is authorized under the appropriate clinical facility procedure to support the patient care. Any inappropriate setting, especially the limit alarm or alarm notification setting can lead the hazardous situation that injures the patient or harms the patient or threats the patient life. The special attention to assign the trained user who can adjust the patient setting of the patient monitor should be essentially paid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112190: Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112190
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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