510(k) · Cleared
ClearedTalking Trach
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Medical Systems, Inc. · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Apr 20, 2007 as substantially equivalent to K962714 (Passy-Muir, Inc., 1996) and 2 other predicates after a 270-day review. Its family tree reaches back 2 generations to 1979. 1 of the 14 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 20, 2007
- Review
- 270 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K792222 (1979). 13 ancestors in all. No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK792222 Shiley Low Pressure Thin-Cuffed Trach.Shiley, Inc. · 1979
- 1 generation backK962173 Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Recalled (Class I)
- This deviceK062104 Talking TrachEngineered Medical Systems, Inc. · 2007
Class I recalls in this family
- K962173 Shikey Tracheostomy Tubes and Accessoriesdirect predicate · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792222 | Shiley Low Pressure Thin-Cuffed Trach. | Shiley, Inc. | 1979 | — |
| −1 | K962173 | Shikey Tracheostomy Tubes and Accessories | Mallinckrodt Medical | 1996 | Class I |
| 0 (this device) | K062104 | Talking Trach | Engineered Medical Systems, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 4 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K962714 | Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valve; Product Number PMV…Summary page 1…Tube, tracheostomy and tube cuff Device: Traceostomy tube with inner cannula Predicate Devices: Passy Muir- K962714 Portex - Trach Talk - K972385 Shiley - Trach tubes -… | 1996 |
| * | K972385 | Fenestrated Flexible D.I.C. Tracheostomy Tube CuffedSummary page 1…Traceostomy tube with inner cannula Predicate Devices: Passy Muir- K962714 Portex - Trach Talk - K972385 Shiley - Trach tubes - K962173 Device Description -- The proposed EMS Talking Trach is a… | 1998 |
| * | K962173 | Shikey Tracheostomy Tubes and AccessoriesSummary page 1…: Passy Muir- K962714 Portex - Trach Talk - K972385 Shiley - Trach tubes - K962173 Device Description -- The proposed EMS Talking Trach is a tracheostomy tube which allows patients who are ventilator dependent… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- 4 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
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. 2007, 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 EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access
for airway management of tracheostomized patient. The device allows tracheostomy
patients with a functional larynx and an unobstructed upper airway to vocalize / phonate.
The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to
remain inflated for ventilator dependent patients. For adult patients > 30 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062104: Talking Trach.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062104
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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