510(k) · Cleared
ClearedNihon Kohden BSM-1101 and BSM-1102 Patient Monitor and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Jan 13, 1998 as substantially equivalent to K914092 (Nihon Kohden America, Inc., 1992) after a 90-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Jan 13, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914092 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK914092 BSM-2100A Configured Patient MonitorNihon Kohden America, Inc. · 1992
- This deviceK973918 Nihon Kohden BSM-1101 and BSM-1102 Patient Monitor and AccessoriesNihon Kohden America, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK992455 Nihon Kohden Ogs-2001A Pocketcare and AccessoriesNihon Kohden America, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K992455Nihon Kohden Ogs-2001A Pocketcare and AccessoriesNihon Kohden America, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914092 | BSM-2100A Configured Patient Monitor | Nihon Kohden America, Inc. | 1992 | — |
| 0 (this device) | K973918 | Nihon Kohden BSM-1101 and BSM-1102 Patient Monitor and Accessories | Nihon Kohden America, Inc. | 1998 | — |
| +1 | K992455 | Nihon Kohden Ogs-2001A Pocketcare and Accessories | Nihon Kohden America, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 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 |
|---|---|---|---|
| * | K914092 | BSM-2100A Configured Patient Monitor Our OCR of the scanned summary read K914082, FDA’s number for Suan Flat Dissector Sponges (Icn Pharmaceuticals, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nihon Kohden BSM-2101A Patient Monitor”. | 1992 |
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 |
|---|---|---|---|
| K992455 | Nihon Kohden Ogs-2001A Pocketcare and Accessories | 2000 | 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?
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The BSM-1101 and BSM-1102 Patient Monitors are intended for medical purposes to measure the heart rate from a signal produced by an electrocardiograph. The devices sound an alarm when the heart rate falls outside preset upper and lower limits. The devices include an oximeter used to transmit radiation at a known wavelength through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. The devices include…
Read the full statement (161 words)
The BSM-1101 and BSM-1102 Patient Monitors are intended for medical purposes to measure the
heart rate from a signal produced by an electrocardiograph. The devices sound an alarm when the
heart rate falls outside preset upper and lower limits. The devices include an oximeter used to
transmit radiation at a known wavelength through blood and to measure the blood oxygen
saturation based on the amount of reflected or scattered radiation. The devices include a
noninvasive blood pressure measurement system that provides a signal from which systolic,
diastolic, and mean pressures can be derived through the use of pressure cuffs placed on the am,
leg or finger. The devices may be used as a radio frequency physiological signal transmitter to
condition physiological signals so that they can be transmitted via radio frequency from one
location to another, e.g. a central monitoring station.
The BSM-1101"and BSM-1102 Patient Montlors will be available for use by medical personnel on
all patient populatiors'within a medical facllity.
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/K973918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973918: Nihon Kohden BSM-1101 and BSM-1102 Patient Monitor and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973918
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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