# K200916: Patient Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Cyclomedica Australia Pty, Ltd.
- Decided: Sep 1, 2020 after 148 days
- Product code: IYT (System, Rebreathing, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.1390
- 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 K913416 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913416: Tetley Patient Administration Set, Tetley Medical, Ltd. (1991) Summary page 4.

## Indications for use
The Patient Administration Set is a radionuclide rebreathing system and an accessory intended solely for use with the TechnegasPlus Technegas® Generator. It is designed for use as a conduit system to contain a radionuclide-labeled aerosol and permit respiration by the patient during a functional lung ventilation imaging diagnostic procedure.

Source page: https://510kreport.com/device/K200916
Methodology: https://510kreport.com/methodology