# K082657: RTX Respirator

- Pathway: 510(k) (Traditional)
- Applicant: Medivent Limited
- Decided: Oct 8, 2008 after 26 days
- Product code: BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass))
- Device class: 2
- Regulation: 21 CFR 868.5935
- 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 K841529 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924341: Hayek Oscillator (TM), Respironics, Inc. (1993) Summary page 1.
- K841529: Siemens-Elema Ventilator 900C, Siemens Elema AB (1984) Summary page 1.
- K884098: Thairapy (TM) Bronchial Drainage System, Model 101, American Biosystems, Inc. (1988) Summary page 1.

## Indications for use
1) Ventilation - The RTX Respirator is indicated for external ventilation of the lungs resulting in gas exchange. 2) Secretion Clearance - Also for use in assisting patients with secretion clearance management as indicated by standard medical convention The RTX Respirator is for use in adult and pediatric patient populations. The RTX is not for use in out-of-hospital transport. For prescription use only.

Source page: https://510kreport.com/device/K082657
Methodology: https://510kreport.com/methodology