510(k) · Cleared
ClearedNihon Kohden Bedside Monitor, Model BSM-6000S Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Feb 26, 2008 as substantially equivalent to K030105 (Nihon Kohden America, Inc., 2003) and 1 other predicate after an 18-day review. Its family tree reaches back 4 generations to 1995. 11 later devices descend from it.
- Decided
- Feb 26, 2008
- Review
- 18 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951127 (1995). 9 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
- 3 generations backK965062 Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc. · 1997
- 2 generations backK020046 Multigas Unit, Model AG-920RANihon Kohden America, Inc. · 2002
- 1 generation backK030105 Anesthesia Monitor; Bedside Monitor, Series BSM-5130ANihon Kohden America, Inc. · 2003
- This deviceK080342 Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK082785 Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK151080 Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · Recalled
- Descendant · cites it directly · 3 of its ownK201949 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series…Nihon Kohden Corporation · 2021
- Descendant · cites it directly · 2 of its ownK083271 BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model…Nihon Kohden America, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK213316 Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit…Nihon Kohden Corporation · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K082785Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008 · cites it directly5descendants
- K151080Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · 2 generations on4descendants
- K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…Nihon Kohden Corporation · 2021 · cites it directly3descendants
- K083271BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series…Nihon Kohden America, Inc. · 2008 · cites it directly2descendants
- K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…Nihon Kohden Corporation · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas Module | Hewlett-Packard GmbH | 1995 | — |
| −3 | K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ Modules | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −2 | K020046 | Multigas Unit, Model AG-920RA | Nihon Kohden America, Inc. | 2002 | — |
| −1 | K030105 | Anesthesia Monitor; Bedside Monitor, Series BSM-5130A | Nihon Kohden America, Inc. | 2003 | — |
| 0 (this device) | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S Series | Nihon Kohden America, Inc. | 2008 | — |
| +1 | 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 | — |
| +1 | K083271 | BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001… | Nihon Kohden America, Inc. | 2008 | — |
| +2 | K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, 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 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K030105 | Anesthesia Monitor; Bedside Monitor, Series BSM-5130ASummary page 1…ssified as Class II by the Anesthesiology Device Classification Panel. Legally Marketed Predicate: Nihon Kohden BSM-5130A Beside Monitor per 510(k) K030105, commercial distribution certification dated March 4, 2003 and Nihon Kohden ORG-9700 Multiple Patient Receiver as per 510(… | 2003 |
| * | K071058 | Multiple Patient Receiver, Model Org-9700ASummary page 1…ide Monitor per 510(k) K030105, commercial distribution certification dated March 4, 2003 and Nihon Kohden ORG-9700 Multiple Patient Receiver as per 510(k) K071058, commercial distribution certification dated June 29, 2007. A Description of the Device: The device is intended t… | 2007 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082785 | Nihon Kohden Bedside Monitor, BSM 9100A Series | 2008 | 5 |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM… | 2021 | 3 |
| K083271 | BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series… | 2008 | 2 |
| K153707 | Nihon Kohden Vital Sign Telemeter | 2016 | 1 |
| K163459 | Nihon Kohden Vital Sign Telemeter | 2017 | 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 3 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K082785 (Nihon Kohden America, Inc., 2008) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K030105.
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. 2008, 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 device is 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 signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive…
Read the full statement (172 words)
The device is 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 signals produced by the heart and monitor the
electrocardiogram to generate audible and/or visible 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), continuous non-invasive blood pressure
(CNIBP), invasive blood pressure (JBP), body temperature, BIS, Cardiac Output (CO),
oxygen concentration (FiO 2), carbon dioxide concentration (CO 2) and EtCO 2, respiratory
rate and inspired and expired anesthetic agents and anesthetic gases including N 2 0,
Halothane, Isoflurane, Enflurane, Sevoflurane and Desfiurane. The device may generate
an audible and/or visual alarm when a measured rate falls outside preset limits. This
device may also be used to condition and transmit physiological signals via radio
frequency.
The device will be available for use by medical personnel on patients within a medical
facility on all patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080342 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080342
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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