# K914092: BSM-2100A Configured Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: May 28, 1992 after 259 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980728: Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System (1998), 2 descendants of its own
- K033711: Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System (2004), 1 descendant of its own
- K973918: Nihon Kohden BSM-1101 and BSM-1102 Patient Monitor and Accessories (1998), 1 descendant of its own
- K971436: Nihon Kohden Tec-7511A/Tec-7521A Cardiolife Portable Defibrillator and Accessories (1997), 1 descendant of its own
- K160667: Anybattery C2 Rechargeable Battery (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K914092
Methodology: https://510kreport.com/methodology