510(k) · Cleared
ClearedBSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series Optional Accessory
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 Dec 24, 2008 as substantially equivalent to K011918 (Nihon Kohden America, Inc., 2001) and 1 other predicate after a 48-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.
- Decided
- Dec 24, 2008
- Review
- 48 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K951127 (1995). 11 ancestors in all. 2 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 deviceK083271 BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model…Nihon Kohden America, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK112637 Netkonnect Remote Network ExtensionNihon Kohden · 2011
- Descendant · 2 generations on · 0 of its ownK220989 Next Generation NetKonnectNihon Kohden Digital Health Solutions, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView 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) | K083271 | BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001… | Nihon Kohden America, Inc. | 2008 | — |
| +1 | K112637 | Netkonnect Remote Network Extension | Nihon Kohden | 2011 | — |
| +2 | K220989 | Next Generation NetKonnect | Nihon Kohden Digital Health Solutions, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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? (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 |
|---|---|---|---|
| * | K011918 | Nihon Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A Series | 2001 |
| * | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesSummary page 1…eries Bedside Monitor and Accessories per 510(k) KO 11918, commercial distribution certification dated September 12, 2001 and BSM-6000 Series Bedside Monitor per 5 10(k) K080342, commercial distribution certification date February 26, 2008. Intended Use: This device is intended to monitor, display and rec… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112637 | Netkonnect Remote Network Extension | 2011 | 1 |
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 11 ancestors has a recall of any class.
- Of its descendants, K112637 (Nihon Kohden, 2011) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K011918.
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 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), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, carbon…
Read the full statement (118 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 (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, carbon dioxide concentration (CO 2 and EtCO 2), and respiratory rate. The device may generate an audible and/or visible alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. This will be available for use by medical personnel on all patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K083271: BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series Optional Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K083271
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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