510(k) · Cleared
ClearedPhoneris Inner Cannulae with Phoneris Aero-Flex Ventilator Circuit Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lazarus Medical, LLC · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Jun 26, 2008 as substantially equivalent to K811447 (Shiley, Inc., 1981) after a 178-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Jun 26, 2008
- Review
- 178 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K811447 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK811447 Shiley Disposable Cannula Trach. TubeShiley, Inc. · 1981
- This deviceK073702 Phoneris Inner Cannulae with Phoneris Aero-Flex Ventilator Circuit…Lazarus Medical, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811447 | Shiley Disposable Cannula Trach. Tube | Shiley, Inc. | 1981 | — |
| 0 (this device) | K073702 | Phoneris Inner Cannulae with Phoneris Aero-Flex Ventilator Circuit Connector | Lazarus Medical, LLC | 2008 | — |
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 BTO? 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 BTO device
- #1 K242921 5300600-5301000 Rota-Trach Disposable Standard…score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K811447 | Shiley Disposable Cannula Trach. TubeSummary page 1…my tube accessory Classification Name: Tracheostomy tube and tube cuff 3. PREDICATE DEVICE Shiley Disposable Cannula Tracheostomy Tube (K81 1447) 4. INTENDED USE The PhonerisTm Inner Cannulae with PhoneriSrm Aero-FleXTM Ventilator Circuit Connector is i… | 1981 |
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.
- 5 other devices also cite its predicate K811447.
How does its category compare?
All BTO devicesBTO Tube, Tracheostomy (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BTO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTO
98in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTO
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BTO
233in 2025
MAUDE reports naming product code BTO, 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 | 1 | — | 0 | 226 |
| 2008 | 1 | — | 0 | 255 |
| 2009 | 1 | — | 2 | 795 |
| 2010 | 3 | 98 | 6 | 130 |
| 2011 | 1 | — | 19 | 54 |
| 2012 | 1 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 78 |
| 2014 | 0 | — | 0 | 173 |
| 2015 | 0 | — | 1 | 172 |
| 2016 | 0 | — | 0 | 212 |
| 2017 | 0 | — | 0 | 126 |
| 2018 | 1 | — | 0 | 162 |
| 2019 | 0 | — | 0 | 87 |
| 2020 | 1 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 198 |
| 2022 | 0 | — | 0 | 770 |
| 2023 | 0 | — | 1 (1) | 402 |
| 2024 | 1 | — | 0 | 418 |
| 2025 | 1 | — | 0 | 233 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Phoneris TM Inner Cannulae with Phoneris M
T
Aero-FlexTM Ventilator Circuit
Connector is indicated for airway maintenance of tracheostomised patients. The
single use, disposable device is an accessory to a tracheostomy tube, serving as an
interlocking, detachable, coupling between the ventilator circuit and tracheostomy
tube. The PhonerisTM Inner Cannulae component is designed to replace the
disposable inner cannulae component of the Shiley Disposable Cannula
Tracheostomy Tube.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073702: Phoneris Inner Cannulae with Phoneris Aero-Flex Ventilator Circuit Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073702
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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