# K102024: RPM Respiratory Gating System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Oct 15, 2010 after 88 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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: 3 generations back to K864886 (1987). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063270: RPM Respiratory Gating System, Varian Medical Systems, Inc. (2006) Summary page 1.

## Most influential descendants
- K151533: Respiratory Gating for Scanners (2015), 3 descendants of its own
- K213927: Respiratory Gating for Scanners v2.0 (2022), 2 descendants of its own
- K253026: Respiratory Gating for Scanners (2.1) (2026), 0 descendants of its own
- K242874: Gating Reflector Block (2024), 0 descendants of its own
- K121845: SDX System (2012), 0 descendants of its own

## Recalls of this device
- Mar 26, 2013 · Class II · Z-1163-2013: Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted re

## Indications for use
The RPM Respiratory Gating System is used to obtain tracking of the subject respiratory pattern for respiratory synchronized image acquisition and radiation therapy treatment. It can also be used to monitor the patient position during image acquisition, simulation and treatment.

Source page: https://510kreport.com/device/K102024
Methodology: https://510kreport.com/methodology