FDA product code BTS: Tube, Bronchial (W/Wo Connector)
BTS is the FDA product code for tube, bronchial (w/wo connector). It is a Class II device, regulated under 21 CFR 868.5720 and reviewed by the Anesthesiology panel. FDA has cleared 6 510(k) submissions under BTS, from 6 different applicants. The average 510(k) review took 70 days (median 88). FDA has posted 11 recalls for BTS devices.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Bronchial (W/Wo Connector) |
| Device class | Class II |
| Regulation | 21 CFR 868.5720 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every BTS clearance
Top BTS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rusch, Inc. | 1 | 1995-11-27 |
| Rusch Intl. | 1 | 1995-06-08 |
| Concord/Portex | 1 | 1990-08-03 |
| Portex, Inc. | 1 | 1984-01-17 |
| Surgitek | 1 | 1983-12-27 |
1 more applicants have BTS clearances. See the full list in Caduvo.
Most recent BTS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953963 | Rusch, Inc. | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION | 1995-11-27 | 97 |
| K951091 | Rusch Intl. | RUSCH ENDOBRONCHIAL TUBE SETS | 1995-06-08 | 91 |
| K902116 | Concord/Portex | MODIFIED ENDOBRONCHIAL TUBE | 1990-08-03 | 85 |
| K834565 | Portex, Inc. | ENDOBRONCHIAL TWIN LUMEN TUBE | 1984-01-17 | 20 |
| K833297 | Surgitek | BRONCHOSCOPY TUBE W/ULTRA LOCUFF | 1983-12-27 | 95 |
Recalls for BTS devices
11 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-11-21.
Frequently asked questions
What is FDA product code BTS?
BTS is the FDA product code for tube, bronchial (w/wo connector). It is a Class II device, regulated under 21 CFR 868.5720 and reviewed by the Anesthesiology panel.
What device class is BTS?
Class II, regulation 21 CFR 868.5720. Typical premarket route: 510(k).
How long does a 510(k) take for product code BTS?
Across 6 cleared submissions the average was 70 days from receipt to decision (median 88).
Which companies have the most BTS clearances?
Rusch, Inc. (1); Rusch Intl. (1); Concord/Portex (1); Portex, Inc. (1); Surgitek (1).
Have BTS devices been recalled?
Yes: 11 product recalls across 3 recall events; the most recent began 2014-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code BTS
- Run a recall and safety report across every BTS manufacturer
- Watch product code BTS 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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