# K002068: ORG-9200A

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Feb 8, 2001 after 216 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.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K071058: Multiple Patient Receiver, Model Org-9700A (2007), 16 descendants of its own
- K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series (2008), 11 descendants of its own
- K082785: Nihon Kohden Bedside Monitor, BSM 9100A Series (2008), 5 descendants of its own
- K151080: Nihon Kohden CSM 1901 Bedside Monitor (2015), 4 descendants of its own
- K201949: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (2021), 3 descendants of its own

Source page: https://510kreport.com/device/K002068
Methodology: https://510kreport.com/methodology