FDA product code BTO: Tube, Tracheostomy (W/Wo Connector)
BTO is the FDA product code for tube, tracheostomy (w/wo connector). It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Anesthesiology panel. FDA has cleared 129 510(k) submissions under BTO, 3 in the last five years, from 77 different applicants. The average 510(k) review took 109 days (median 77); 245 days on average over the last three years. FDA has posted 73 recalls for BTO devices, 33 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class II |
| Regulation | 21 CFR 868.5800 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BTO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 162 |
| 2020 | 1 | 314 |
| 2024 | 1 | 123 |
| 2025 | 1 | 259 |
| 2026 | 1 | 354 |
Compare with all 510(k) review times · Search every BTO clearance
Top BTO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shiley, Inc. | 13 | 1990-04-23 |
| Bivona Medical Technologies | 6 | 1992-07-27 |
| American Healthcare Corp. | 5 | 1993-06-16 |
| Frederic J. Toye, M.D. | 5 | 1987-06-08 |
| Hood Laboratories | 4 | 1989-08-07 |
72 more applicants have BTO clearances. See the full list in Caduvo.
Most recent BTO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253063 | Vitaltec Corporation | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) | 2026-09-11 | 354 |
| K242921 | Vitaltec Corporation | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm | 2025-06-10 | 259 |
| K233713 | Teleflex Medical | Pilling Tracheostomy Tubes | 2024-03-22 | 123 |
| K192511 | Venner Medical (Singapore) Pte, Ltd. | Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm | 2020-07-22 | 314 |
| K173384 | Smiths Medical Ads, Inc. | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube | 2018-04-10 | 162 |
Recalls for BTO devices
73 product recalls in 22 recall events; 33 initiated in the last five years and 33 still open. Most recent: 2026-04-23.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| 2024 | 31 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code BTO?
BTO is the FDA product code for tube, tracheostomy (w/wo connector). It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Anesthesiology panel.
What device class is BTO?
Class II, regulation 21 CFR 868.5800. Typical premarket route: 510(k).
How long does a 510(k) take for product code BTO?
Across 129 cleared submissions the average was 109 days from receipt to decision (median 77).
Which companies have the most BTO clearances?
Shiley, Inc. (13); Bivona Medical Technologies (6); American Healthcare Corp. (5); Frederic J. Toye, M.D. (5); Hood Laboratories (4).
Have BTO devices been recalled?
Yes: 73 product recalls across 22 recall events; the most recent began 2026-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code BTO
- Run a recall and safety report across every BTO manufacturer
- Watch product code BTO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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