# K043517: Transmitter, ZS-940PA Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Nihon Kohden America, Inc.
- Decided: Feb 3, 2005 after 45 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
No predicates in its family tree.
65 later devices descend from it; 3 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nihon Kohden predicate devices: named in the summary without a submission number

## Most influential descendants
- K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model (2010), 37 descendants of its own
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own
- K112478: Visi Mobile Monitoring System (2012), 24 descendants of its own

## Indications for use
The device is intended to transmit physiological data, such as: ele6trocardiogram (ECG), respiration, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and pulse waveform from a patient to a Nihon Kohden monitor for continuous monitoring. The transmitter can change channels when connected to the QI-9OPK channel writer. The front LCD displays SPO2%, NlBP, pulse rate, pulse waveform amplitude, electrode condition mark, battery condition and NIBP measuring mode and interval. The system communicates in the new WMTS band as required by FCC. The device will be available for use within a medical facility, including ICU, CCU, recovery room and general ward by medical personnel on adults and children for NIBP and all other functions for all patient populations, including neonates.

Source page: https://510kreport.com/device/K043517
Methodology: https://510kreport.com/methodology