510(k) · Cleared
ClearedNihon Kohden Vital Sign Telemeter
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 Apr 4, 2017 as substantially equivalent to K080342 (Nihon Kohden America, Inc., 2008) and 1 other predicate after a 116-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Apr 4, 2017
- Review
- 116 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K951127 (1995). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
- 5 generations backK965062 Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc. · 1997
- 4 generations backK020046 Multigas Unit, Model AG-920RANihon Kohden America, Inc. · 2002
- 3 generations backK030105 Anesthesia Monitor; Bedside Monitor, Series BSM-5130ANihon Kohden America, Inc. · 2003
- 2 generations backK080342 Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008
- 1 generation backK153707 Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation · 2016
- This deviceK163459 Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas Module | Hewlett-Packard GmbH | 1995 | — |
| −5 | K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ Modules | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −4 | K020046 | Multigas Unit, Model AG-920RA | Nihon Kohden America, Inc. | 2002 | — |
| −3 | K030105 | Anesthesia Monitor; Bedside Monitor, Series BSM-5130A | Nihon Kohden America, Inc. | 2003 | — |
| −2 | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S Series | Nihon Kohden America, Inc. | 2008 | — |
| −1 | K153707 | Nihon Kohden Vital Sign Telemeter | Nihon Kohden Corporation | 2016 | — |
| 0 (this device) | K163459 | Nihon Kohden Vital Sign Telemeter | Nihon Kohden Corporation | 2017 | — |
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 |
| 2005 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesSummary page 4…870.1025 Secondary Product Code: DRG Regulation: 21 CFR 870.2910 Substantial equivalent Nihon Kohden BSM-6000 Series Bedside Monitor (K080342) and claimed to: Nihon Kohden Vital Sign Telemeter GZ-120P and GZ-130P (K153707… | 2008 |
| * | K153707 | Nihon Kohden Vital Sign TelemeterSummary page 4…Kohden BSM-6000 Series Bedside Monitor (K080342) and claimed to: Nihon Kohden Vital Sign Telemeter GZ-120P and GZ-130P (K153707) Description: The Nihon Kohden Vital Sign Telemeter GZ-140P is mainly used as a telemetry system within a medical facility. The… | 2016 |
| † | K040490 | Welch Allyn Spot Ultra Vital Signs Device | 2004 |
| † | K152305 | Nihon Kohden Afib Detection Program QP-039P | 2016 |
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 22 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 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. 2017, 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 Vital Sign Telemeter GZ-140P is intended to monitor and transmit physiological data from a patient to a Nihon Kohden monitor via radiofrequency in the 802.11 band for continuous monitoring. GZ-140P transmits electrocardiogram (ECG), respiration data, blood oxygen saturation (SpO2) and non-invasive blood pressure (NIBP). The device may generate an audible and/or visible alarm when an arrhythmia exists, when a measured physiological rate…
Read the full statement (157 words)
The Nihon Kohden Vital Sign Telemeter GZ-140P is intended to monitor and transmit physiological data from a patient to a Nihon Kohden monitor via radiofrequency in the 802.11 band for continuous monitoring. GZ-140P transmits electrocardiogram (ECG), respiration data, blood oxygen saturation (SpO2) and non-invasive blood pressure (NIBP). The device may generate an audible and/or visible alarm when an arrhythmia exists, when a measured physiological rate falls outside preset limits, or when a technical error is detected. Furthermore, the device can be configured for use as a temporary simple monitor to display the patient’s vital signs on the device screen and generate alarms without transmitting the data to other Nihon Kohden monitor.
The device is intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups, with the exception of NIBP measurement which is not intended for use on neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163459: Nihon Kohden Vital Sign Telemeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163459
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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