# K092845: Respisens

- Pathway: 510(k) (Traditional)
- Applicant: Nomics
- Decided: Jan 26, 2010 after 133 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: 3 generations back to K864886 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983629: RPM Respiratory Gating System, Varian Medical Systems, Inc. (1999) Summary page 1.
- K063270: RPM Respiratory Gating System, Varian Medical Systems, Inc. (2006) Summary page 1.
- K003330: Aktina Medical Physics Corporation Active Breathing Coordinator (Abc), Aktina Medical Physics Corp. (2001) Summary page 1.

## Most influential descendants
- K112841: Surface Beacon Transponders (2012), 0 descendants of its own

## Indications for use
The Respisens system is intended to monitor patient motion in real time during radiotherapy. In particular, the system is intended to monitor breath hold and to detect undesirable patient motion. Monitoring respiratory motion during breath hold is essential in ensuring patient safety. The system warns the operator when breath hold is not maintained properly. Verifying that the patient stays completely still during treatment is also fundamental. The system can detect patient movement and warn the operator when necessary.

Source page: https://510kreport.com/device/K092845
Methodology: https://510kreport.com/methodology