# K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Medtec, Inc. D/B/A Civco Medical Solutions
- Decided: May 25, 2016 after 222 days
- Product code: IYE (Accelerator, Linear, 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: 6 generations back to K935300 (1994). 34 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122888: CDR Systems Precision Patient Positioning System, Cdr Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K210894: Siddharth-II; Impact (2021), 1 descendant of its own
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own
- K171133: Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories (2017), 0 descendants of its own

## Indications for use
The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.

Source page: https://510kreport.com/device/K153026
Methodology: https://510kreport.com/methodology