510(k) · Cleared
ClearedLucon M-Series Patient Monitor, Models M20 and M30
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 Jun 8, 2010 as substantially equivalent to K082812 (Omron Healthcare, Inc., 2008) and 3 other predicates after a 134-day review. Its family tree reaches back 8 generations to 1997. 1 later device descends from it.
- Decided
- Jun 8, 2010
- Review
- 134 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K962603 (1997). 62 ancestors in all, the oldest K872291 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 3 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 2 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 1 generation backK062095 Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2006
- This deviceK100217 Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK112190 Patient MonitorMediana Co., Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K112190Patient MonitorMediana Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −3 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −2 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −1 | K062095 | Mcare 300 Vital Signs Monitor, Model 91220 | Spacelabs Medical, Inc. | 2006 | — |
| 0 (this device) | K100217 | Lucon M-Series Patient Monitor, Models M20 and M30 | Mediana Co., Ltd. | 2010 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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.
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 2…te Devices (Legally Marketed Devices) The Mediana patient monitors, Model Lucon M-Senies (M20, M30) are substantially equivalent to the HBP-2070 of Omron Healtheare(No. 1K082812), SureSigns VM6 series of Philips Medical Systems (No. 1K080495). and Propaq Encore Model 200 series of Welch Allyn Inc (No. K012… | 2008 |
| * | K080495 | Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Summary page 1…cleared by FDA through 510(k) No. 1(082812, and * Philips Medical Systems Co.,Ltd. Patient Monitors, SureSigns VM6 series cleared by FDA through 510(k) No. 1K080495, and * Welch Allyn Protocol Inc. Cardiac Monitors, Propaq Encore 200 series cleared by FDA through 5 10(k) No. K012451… | 2008 |
| * | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Summary page 1…cleared by FDA through 510(k) No. 1K080495, and * Welch Allyn Protocol Inc. Cardiac Monitors, Propaq Encore 200 series cleared by FDA through 5 10(k) No. K012451, and * Spacelabs Hlealthcare Inc. Vital Signs Monitors, Model 91220 cleared by FDA through 5 10(k) No.1(062095. Devic… | 2001 |
| * | K062095 | Mcare 300 Vital Signs Monitor, Model 91220Summary page 1…ries cleared by FDA through 5 10(k) No. K012451, and * Spacelabs Hlealthcare Inc. Vital Signs Monitors, Model 91220 cleared by FDA through 5 10(k) No.1(062095. Device Description The Mediana Lucon M-series (M20, M30) patient monitor is a lightweight and compact device (250 210 x~ 170 (m… | 2006 |
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 |
|---|---|---|---|
| K112190 | Patient Monitor | 2011 | 0 |
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 13 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 62 ancestors have a recall of any class.
- Of its descendants, K112190 (Mediana Co., Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 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. 2010, 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 Lucon M-series (M20, M30) is intended to be used to monitor 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. The device is capable of monitoring: * Electrocardiography (ECG) * Heart rate (HR) * Noninvasive blood pressure (NIBP) * Functional arterial oxygen saturation (SpO2) * Pulse rate (PR) * Respiration rate (RR) * Temperature (Temp) *…
Read the full statement (228 words)
The Lucon M-series (M20, M30) is intended to be used to monitor 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. The device is capable of monitoring:
* Electrocardiography (ECG)
* Heart rate (HR)
* Noninvasive blood pressure (NIBP)
* Functional arterial oxygen saturation (SpO2)
* Pulse rate (PR)
* Respiration rate (RR)
* Temperature (Temp)
* Arrhythmia/ST segment (M30 only)
* Capnography (M30 only)
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, 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 patient monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100217: Lucon M-Series Patient Monitor, Models M20 and M30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100217
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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