510(k) · Cleared
ClearedNihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corporation · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jul 16, 2021 as substantially equivalent to K201949 (Nihon Kohden Corporation, 2021) after a 235-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Jul 16, 2021
- Review
- 235 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K951127 (1995). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
- 7 generations backK965062 Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc. · 1997
- 6 generations backK020046 Multigas Unit, Model AG-920RANihon Kohden America, Inc. · 2002
- 5 generations backK030105 Anesthesia Monitor; Bedside Monitor, Series BSM-5130ANihon Kohden America, Inc. · 2003
- 4 generations backK080342 Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008
- 3 generations backK082785 Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008
- 2 generations backK151080 Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · Recalled
- 1 generation backK201949 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series…Nihon Kohden Corporation · 2021
- This deviceK203435 Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden…Nihon Kohden Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas Module | Hewlett-Packard GmbH | 1995 | — |
| −7 | K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ Modules | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −6 | K020046 | Multigas Unit, Model AG-920RA | Nihon Kohden America, Inc. | 2002 | — |
| −5 | K030105 | Anesthesia Monitor; Bedside Monitor, Series BSM-5130A | Nihon Kohden America, Inc. | 2003 | — |
| −4 | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S Series | Nihon Kohden America, Inc. | 2008 | — |
| −3 | K082785 | Nihon Kohden Bedside Monitor, BSM 9100A Series | Nihon Kohden America, Inc. | 2008 | — |
| −2 | K151080 | Nihon Kohden CSM 1901 Bedside Monitor | Nihon Kohden | 2015 | 1 |
| −1 | K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life… | Nihon Kohden Corporation | 2021 | — |
| 0 (this device) | K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope… | Nihon Kohden Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM… Cleared while this submission was under review Summary page 7…-1. Table of CSM-1901 (G9) Bedside Monitoring System Information 510(k) Product 510(k) Holder Clearance Date K201949 CSM-1901 Nihon Kohden Corporation May 02, 2021 11.1.4 Comparison to Predicate Device The… | 2021 |
| † | K110594 | GF-210R Multi-Gas Module for Nohon Kohden Bedside Monitors | 2011 |
| † | K074705 | sensor JO-900P | |
| † | K060576 | Nellcor Oximax N-600X Pulse Oximeter | 2006 |
| † | K053269 | Masimo Set Rad-8 Pulse Oximeter | 2005 |
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 26 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- 4 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K201949.
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. 2021, 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 Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to…
Read the full statement (206 words)
The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.
The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.
A-fib detection, ST measurement and QTc/QRSd monitoring intended for adult patient . rrhythmia detection function is intended for adolescent and .
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203435: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203435
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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