510(k) · Cleared
ClearedNihon Kohden Bedside Monitor, BSM 9100A 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 Nov 26, 2008 as substantially equivalent to K080342 (Nihon Kohden America, Inc., 2008) after a 64-day review. Its family tree reaches back 5 generations to 1995. 5 later devices descend from it.
- Decided
- Nov 26, 2008
- Review
- 64 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K951127 (1995). 10 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
- 4 generations backK965062 Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc. · 1997
- 3 generations backK020046 Multigas Unit, Model AG-920RANihon Kohden America, Inc. · 2002
- 2 generations backK030105 Anesthesia Monitor; Bedside Monitor, Series BSM-5130ANihon Kohden America, Inc. · 2003
- 1 generation backK080342 Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008
- This deviceK082785 Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK151080 Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK201949 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series…Nihon Kohden Corporation · 2021
- Descendant · 3 generations on · 1 of its ownK213316 Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit…Nihon Kohden Corporation · 2021
- Descendant · 4 generations on · 0 of its ownK220976 Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK203435 Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden…Nihon Kohden Corporation · 2021
Most influential descendants
Showing 5 of 5 · See all- K151080Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · cites it directly4descendants
- K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…Nihon Kohden Corporation · 2021 · 2 generations on3descendants
- K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…Nihon Kohden Corporation · 2021 · 3 generations on1descendant
- K220976Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation · 2022 · 4 generations on0descendants
- K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside…Nihon Kohden Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas Module | Hewlett-Packard GmbH | 1995 | — |
| −4 | K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ Modules | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −3 | K020046 | Multigas Unit, Model AG-920RA | Nihon Kohden America, Inc. | 2002 | — |
| −2 | K030105 | Anesthesia Monitor; Bedside Monitor, Series BSM-5130A | Nihon Kohden America, Inc. | 2003 | — |
| −1 | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S Series | Nihon Kohden America, Inc. | 2008 | — |
| 0 (this device) | K082785 | Nihon Kohden Bedside Monitor, BSM 9100A Series | Nihon Kohden America, Inc. | 2008 | — |
| +1 | K151080 | Nihon Kohden CSM 1901 Bedside Monitor | Nihon Kohden | 2015 | 1 |
| +2 | K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life… | Nihon Kohden Corporation | 2021 | — |
| +3 | K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE… | Nihon Kohden Corporation | 2021 | — |
| +4 | K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | 2022 | — |
| +3 | 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 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesSummary page 1…Class II by the Anesthesiology Device Classification Panel. Legally Marketed Predicate Device: Nihon Kohden BSM-6000 Series Bedside Monitor and Accessories per 5 10(k) K080342 commercial distribution certification dated February 26, 2008. Intended Use: The device is intended to monitor, display and re… | 2008 |
| † | K020046 | Multigas Unit, Model AG-920RA | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151080 | Nihon Kohden CSM 1901 Bedside Monitor | 2015 | 4 |
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 2.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K151080 (Nihon Kohden, 2015) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K080342.
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 visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive…
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 visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO 2), Carbon dioxide Concentration (C0 2) and EtCO 2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including C0 2, 02, N 2 0, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System K020046 cleared for distribution on July 23, 2002. The device also monitors Ventilators, CO 2 Monitors, TOF Monitors, BIS Monitors and CCO/SvO 2 Monitors .The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082785: Nihon Kohden Bedside Monitor, BSM 9100A Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082785
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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