FDA product code BRX: Stool, Anesthesia
BRX is the FDA product code for stool, anesthesia. It is a Class I device, regulated under 21 CFR 868.6700 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under BRX. The average 510(k) review took 111 days (median 111). FDA has posted 1 recall for BRX devices.
Classification
| Field | Value |
|---|---|
| Device name | Stool, Anesthesia |
| Device class | Class I |
| Regulation | 21 CFR 868.6700 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BRX clearance
Top BRX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3M Health Care, Ltd. | 1 | 1992-12-23 |
Most recent BRX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924487 | 3M Health Care, Ltd. | RED DOT 2515 CARDIAC SENSOR SYSTEM | 1992-12-23 | 111 |
Recalls for BRX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2019-07-10.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code BRX?
BRX is the FDA product code for stool, anesthesia. It is a Class I device, regulated under 21 CFR 868.6700 and reviewed by the Anesthesiology panel.
What device class is BRX?
Class I, regulation 21 CFR 868.6700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BRX?
Across 1 cleared submissions the average was 111 days from receipt to decision (median 111).
Which companies have the most BRX clearances?
3M Health Care, Ltd. (1).
Have BRX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code BRX
- Run a recall and safety report across every BRX manufacturer
- Watch product code BRX 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.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times