# K071058: Multiple Patient Receiver, Model Org-9700A

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jun 29, 2007 after 74 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002068 (2001). 1 ancestor in all.
16 later devices descend from it; 3 cite 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)
- K002068: ORG-9200A, Nihon Kohden America, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K110809: Wireless Monitoring System (2011), 2 descendants of its own

## Recalls of this device
- Jan 8, 2021 · Class II · Z-1162-2021: Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

## Indications for use
The ORG-9700A Multiple Patient Receiver is intended for use by medical professionals with Nihon Kohden telemetry transmitters and central stations to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The device detects patient vital sign alarm conditions and includes an algorithm to detect cardiac arrhythmias. The intended use of the modified device has not changed as a result of the modifications. The device is available for use on all patient populations.

Source page: https://510kreport.com/device/K071058
Methodology: https://510kreport.com/methodology