FDA product code BTG: Brush, Biopsy, Bronchoscope (Non-Rigid)
BTG is the FDA product code for brush, biopsy, bronchoscope (non-rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 6 510(k) submissions under BTG, 1 in the last five years, from 6 different applicants. The average 510(k) review took 184 days (median 136); 49 days on average over the last three years. FDA has posted 2 recalls for BTG devices.
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Brush, Biopsy, Bronchoscope (Non-Rigid) |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BTG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 172 |
| 2020 | 1 | 473 |
| 2025 | 1 | 49 |
Compare with all 510(k) review times · Search every BTG clearance
Top BTG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Medical Systems Corporation | 1 | 2025-06-12 |
| Hobbs Medical, Inc. | 1 | 2020-02-07 |
| Olympus Medical Systems Corp. | 1 | 2019-08-02 |
| Covidien, LLC | 1 | 2013-11-06 |
| Mill-Rose Laboratory | 1 | 1982-05-03 |
1 more applicants have BTG clearances. See the full list in Caduvo.
Most recent BTG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251279 | Olympus Medical Systems Corporation | Disposable Cytology Brush BC-202D/203D Series | 2025-06-12 | 49 |
| K182927 | Hobbs Medical, Inc. | Pulmonary Cytology Brush | 2020-02-07 | 473 |
| K190293 | Olympus Medical Systems Corp. | Single Use Cytology Brush BC-205D | 2019-08-02 | 172 |
| K130357 | Covidien, LLC | SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH | 2013-11-06 | 266 |
| K820771 | Mill-Rose Laboratory | MICROBIOLOGY SPECIMEN BRUSH | 1982-05-03 | 41 |
Recalls for BTG devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-12-08.
Frequently asked questions
What is FDA product code BTG?
BTG is the FDA product code for brush, biopsy, bronchoscope (non-rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is BTG?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code BTG?
Across 6 cleared submissions the average was 184 days from receipt to decision (median 136).
Which companies have the most BTG clearances?
Olympus Medical Systems Corporation (1); Hobbs Medical, Inc. (1); Olympus Medical Systems Corp. (1); Covidien, LLC (1); Mill-Rose Laboratory (1).
Have BTG devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2005-12-08.
Next steps
- Run an FDA pathway report with predicate devices for product code BTG
- Run a recall and safety report across every BTG manufacturer
- Watch product code BTG 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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