# K983629: RPM Respiratory Gating System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 8, 1999 after 236 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864886 (1987). 1 ancestor in all.
108 later devices descend from it; 7 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864886: Respigraph-Respisomnograph-Respicentral, Nims/Respitrace Corp. (1987) Summary page 1.

## Most influential descendants
- K063270: RPM Respiratory Gating System (2006), 83 descendants of its own
- K092871: Trilogy MX (2009), 61 descendants of its own
- K111106: Truebeam (2011), 43 descendants of its own
- K123291: Truebeam (2012), 37 descendants of its own
- K123808: Agility (2013), 36 descendants of its own

## Indications for use
The Varian RPM Respiratory Gating device is an attachment to the radiation therapy simulator and Varian Clinac radiation therapy treatment system. It is to be used to characterize (in simulation) the patient’s respiratory patterns and then, in treatment, to trigger beam-hold and limit the beam-on time to those points in the respiratory cycle where the target volume is within acceptable motion limits.

Source page: https://510kreport.com/device/K983629
Methodology: https://510kreport.com/methodology