FDA product code CBI: Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBI is the FDA product code for tube, tracheal/bronchial, differential ventilation (w/wo connector). It is a Class II device, regulated under 21 CFR 868.5740 and reviewed by the Anesthesiology panel. FDA has cleared 34 510(k) submissions under CBI, 5 in the last five years, from 23 different applicants. The average 510(k) review took 174 days (median 137); 236 days on average over the last three years. FDA has posted 10 recalls for CBI devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
| Device class | Class II |
| Regulation | 21 CFR 868.5740 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for CBI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 200 |
| 2020 | 1 | 262 |
| 2021 | 2 | 304 |
| 2022 | 1 | 120 |
| 2023 | 1 | 111 |
| 2024 | 1 | 266 |
| 2026 | 2 | 206 |
Compare with all 510(k) review times · Search every CBI clearance
Top CBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Etview , Ltd. | 4 | 2018-11-14 |
| Cook, Inc. | 4 | 2002-08-14 |
| Pulmonx Corporation | 2 | 2026-02-13 |
| Shenzhen Insighters Medical Technology Co., Ltd. | 2 | 2024-05-13 |
| Pulmonx, Inc. | 2 | 2011-09-29 |
18 more applicants have CBI clearances. See the full list in Caduvo.
Most recent CBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251950 | Hangzhou Tappa Medical Technology Co., Ltd. | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) | 2026-03-20 | 268 |
| K253096 | Pulmonx Corporation | Chartis Precision Catheter | 2026-02-13 | 143 |
| K232529 | Shenzhen Insighters Medical Technology Co., Ltd. | Disposable Double Lumen Endobronchial Tube | 2024-05-13 | 266 |
| K232580 | Shenzhen Insighters Medical Technology Co., Ltd. | Disposable Endobronchial Blocker Tube | 2023-12-14 | 111 |
| K222340 | Pulmonx Corporation | Chartis Precision Catheter | 2022-12-01 | 120 |
Recalls for CBI devices
10 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-09-16.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code CBI?
CBI is the FDA product code for tube, tracheal/bronchial, differential ventilation (w/wo connector). It is a Class II device, regulated under 21 CFR 868.5740 and reviewed by the Anesthesiology panel.
What device class is CBI?
Class II, regulation 21 CFR 868.5740. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBI?
Across 34 cleared submissions the average was 174 days from receipt to decision (median 137).
Which companies have the most CBI clearances?
Etview , Ltd. (4); Cook, Inc. (4); Pulmonx Corporation (2); Shenzhen Insighters Medical Technology Co., Ltd. (2); Pulmonx, Inc. (2).
Have CBI devices been recalled?
Yes: 10 product recalls across 6 recall events; the most recent began 2024-09-16.
Next steps
- Run an FDA pathway report with predicate devices for product code CBI
- Run a recall and safety report across every CBI manufacturer
- Watch product code CBI 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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