510(k) · Cleared
ClearedLife Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corporation · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on Dec 29, 2021 as substantially equivalent to K201949 (Nihon Kohden Corporation, 2021) after an 86-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Dec 29, 2021
- Review
- 86 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K951127 (1995). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
- 7 generations backK965062 Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc. · 1997
- 6 generations backK020046 Multigas Unit, Model AG-920RANihon Kohden America, Inc. · 2002
- 5 generations backK030105 Anesthesia Monitor; Bedside Monitor, Series BSM-5130ANihon Kohden America, Inc. · 2003
- 4 generations backK080342 Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008
- 3 generations backK082785 Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008
- 2 generations backK151080 Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · Recalled
- 1 generation backK201949 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series…Nihon Kohden Corporation · 2021
- This deviceK213316 Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit…Nihon Kohden Corporation · 2021
- Descendant · cites it directly · 0 of its ownK220976 Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K220976Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas Module | Hewlett-Packard GmbH | 1995 | — |
| −7 | K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ Modules | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −6 | K020046 | Multigas Unit, Model AG-920RA | Nihon Kohden America, Inc. | 2002 | — |
| −5 | K030105 | Anesthesia Monitor; Bedside Monitor, Series BSM-5130A | Nihon Kohden America, Inc. | 2003 | — |
| −4 | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S Series | Nihon Kohden America, Inc. | 2008 | — |
| −3 | 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 | — |
| 0 (this device) | K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE… | Nihon Kohden Corporation | 2021 | — |
| +1 | K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KOI? 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 KOI device
- #1 K261098 TetraGraph Neuromuscular Transmission Monitor…score 21.1 · 39 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 |
|---|---|---|---|
| * | K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…Summary page 7…Special 510(K) Type of Modification Software Modification Predicate K201949 – cleared 2 May2021 • Life Scope® BSM-6000 Series Bedside… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | 2022 | 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 26 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K220976 (Nihon Kohden Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201949.
How does its category compare?
All KOI devicesKOI Stimulator, Nerve, Peripheral, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KOI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOI
174in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOI
No recall names KOI since 2007.
Adverse event reports per year · KOI
5in 2025
MAUDE reports naming product code KOI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 3 | 174 | 0 | 4 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered. The Smart Cable NMT Module and Accessories are comprised of: * AF-201P NMT Module with Smart Cable * Disposable Electrodes * Main cable * Holder (optional) The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring…
Read the full statement (906 words)
The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.
The Smart Cable NMT Module and Accessories are comprised of:
* AF-201P NMT Module with Smart Cable
* Disposable Electrodes
* Main cable
* Holder (optional)
The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.
Life Scope® BSM-6000 Series Bedside Monitoring Systems
The Life Scope® BSM-6000 Series Bedside Monitoring Systems are 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), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (C02), EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include C02 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors, rS02 monitors and external devices which output analog voltage signal.
The device will be available for use by medical personnel on patients within a medical facility on all patient populations.
The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
Life Scope® CSM-1901 Bedside Monitoring Systems
The Life Scope® CSM-1901 Bedside Monitoring Systems are 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 signal 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), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (C02), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, CCO/SvO2 monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits.
The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.
The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
Life Scope® PT BSM-1700 Series and Accessories
The Life Scope® PT BSM-1700 Series and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series input unit monitors physiological data and may generate an audible and/or visual alarm when a measured rate falls outside preset limits when disconnected from the core unit of the device. The input unit can be removed from one core unit and connected to another devices core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device to another device by using with or without WLAN technology. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (C02), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS).
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.
AY Series and Accessories
AY Series and Accessories are intended to acquire and transfer electrical impulses from the patient to the core unit of the device. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (C02), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit adds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems.
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213316: Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213316
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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