510(k) · Cleared
ClearedNihon Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A 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 Sep 12, 2001 as substantially equivalent to K001693 (Nihon Kohden America, Inc., 2000) after an 84-day review. Its family tree reaches back 1 generation to 2000. 20 later devices descend from it.
- Decided
- Sep 12, 2001
- Review
- 84 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001693 (2000). 20 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK001693 Life Scope P, Model BSM-4100 SeriesNihon Kohden America, Inc. · 2000
- This deviceK011918 Nihon Kohden BSM-2300A Series Bedside Monitor and Accessories, Model…Nihon Kohden America, Inc. · 2001
- Descendant · cites it directly · 13 of its ownK113165 Mini-MedicAthena Gtx · 2012
- Descendant · 2 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · 3 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · 4 generations on · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK222658 Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K113165Mini-MedicAthena Gtx · 2012 · cites it directly13descendants
- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 2 generations on12descendants
- K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 3 generations on5descendants
- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · 4 generations on2descendants
- K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001693 | Life Scope P, Model BSM-4100 Series | Nihon Kohden America, Inc. | 2000 | — |
| 0 (this device) | K011918 | Nihon Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A… | Nihon Kohden America, Inc. | 2001 | — |
| +1 | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
| +2 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +3 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +4 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +3 | K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K001693 | Life Scope P, Model BSM-4100 SeriesSummary page 1…or the device is Physiological Patient Monitor with Arrhytmia Detection and Alarms Legally Marketed Predicate: Nihon Kohden BMS-4100A Series Bedside Monitor per 510(k)# K001693. Description and Intended Use: The device is a multi-parameter monitor consisting of a color LCD touch- screen to display wavefo… | 2000 |
What descends from it? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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 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 (SpO_) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, carbon…
Read the full statement (117 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 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 (SpO_) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, carbon dioxide concentration (CO, and EtCO,), and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. The device will be available for use by medical personnel on all patient populations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011918 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011918: Nihon Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011918
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026