# K973918: Nihon Kohden BSM-1101 and BSM-1102 Patient Monitor and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jan 13, 1998 after 90 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914092 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914092: BSM-2100A Configured Patient Monitor, Nihon Kohden America, Inc. (1992). 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”.

## Most influential descendants
- K992455: Nihon Kohden Ogs-2001A Pocketcare and Accessories (2000), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K973918
Methodology: https://510kreport.com/methodology