510(k) · Cleared
ClearedVenti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitaltec Corporation · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Sep 11, 2026 as substantially equivalent to K242921 (Vitaltec Corporation, 2025) after a 354-day review. Its family tree reaches back 6 generations to 1990. 1 of the 13 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 11, 2026
- Review
- 354 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903730 (1990). 12 ancestors in all, the oldest K811033 (1981). No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 5 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 4 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 3 generations backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- 2 generations backK173384 BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont…Smiths Medical Ads, Inc. · 2018 · Recalled (Class I)
- 1 generation backK242921 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube…Vitaltec Corporation · 2025
- This deviceK253063 Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy…Vitaltec Corporation · 2026
Class I recalls in this family
- K173384 BLUselect, non-fenestrated, BLUselect…2 generations back · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −5 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −4 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −3 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| −2 | K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect… | Smiths Medical Ads, Inc. | 2018 | Class I |
| −1 | K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed… | Vitaltec Corporation | 2025 | — |
| 0 (this device) | K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571… | Vitaltec Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 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? (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 |
|---|---|---|---|
| * | K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…Summary page 5…mon Name Tracheostomy Tube 3. Predicate Device Proprietary Name Rota-Trach Disposable Standard Tracheostomy Tube Premarket Notification K242921 Regulation Number 21 CFR 868.5800 Regulation Name Tracheostomy tube and tube cuff Regulatory Class… | 2025 |
| † | K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated… | 2018 |
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.
- K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid…Smiths Medical Ads, Inc. · 2018 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 6 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 12 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. 2026, 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?
Venti-Trach tracheostomy tube is indicated for airway maintenance of tracheostomized patients. The device is operated by health professionals in medical institutions for single patient use. It may be continuous use by replacement and each one should be used within 29 days.
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/K253063 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253063: Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253063
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026