# K212622: Zyter RPM

- Pathway: 510(k) (Traditional)
- Applicant: Zyter, Inc.
- Decided: Feb 11, 2022 after 177 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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: 8 generations back to K962827 (1997). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193421: Smart Alarm Interface, Boxview, LLC (2020) Summary page 4.
- K151006: EarlySense Central Display Station (CDS), Earlysense, Ltd. (2015) Summary page 4.

## Indications for use
The intended use of the Zyter RPM is to provide an interface with physiological patient monitoring systems to forward recorded device information to the patient’s healthcare provider. Zyter RPM does not alter the behavior of the primary medical devices and associated alert annunciations. Zyter RPM is not intended to be used for diagnostic purposes. Zyter RPM is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the use environment (e.g., healthcare facility or home setting) and the display interface used. Zyter RPM is a software product and cannot come into physical contact with patients.

Source page: https://510kreport.com/device/K212622
Methodology: https://510kreport.com/methodology