510(k) · Cleared
ClearedPatient Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyclomedica Australia Pty, Ltd. · IYT System, Rebreathing, Radionuclide
Cleared on Sep 1, 2020 as substantially equivalent to K913416 (Tetley Medical, Ltd., 1991) after a 148-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 1, 2020
- Review
- 148 days
- Class
- Class II
- Product code
- IYT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913416 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913416 Tetley Patient Administration SetTetley Medical, Ltd. · 1991
- This deviceK200916 Patient Administration SetCyclomedica Australia Pty, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913416 | Tetley Patient Administration Set | Tetley Medical, Ltd. | 1991 | — |
| 0 (this device) | K200916 | Patient Administration Set | Cyclomedica Australia Pty, Ltd. | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYT device
- #1 K253942 Pulmonex II Xenon System (132-503)score 11.6 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913416 | Tetley Patient Administration SetSummary page 4…e Rebreathing System Classification Class 2 Regulation No. 21 CFR 892.1390 Product Code IYT Predicate Device Patient Administration Set (510(k) # K913416 ) Modifications The modifications include: x Labeling changes to identify the current device owner… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All IYT devicesIYT System, Rebreathing, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · IYT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · IYT
Too few IYT 510(k)s in any year since 2007 to give a median.
Recalls per year · IYT
No recall names IYT since 2007.
Adverse event reports per year · IYT
2in 2025
MAUDE reports naming product code IYT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200916: Patient Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200916
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026