FDA product code EPE: Brush, Cleaning, Tracheal Tube
EPE is the FDA product code for brush, cleaning, tracheal tube. It is a Class I device, regulated under 21 CFR 868.5795 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under EPE, from 2 different applicants. The average 510(k) review took 30 days (median 30). FDA has posted 1 recall for EPE devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Brush, Cleaning, Tracheal Tube |
| Device class | Class I |
| Regulation | 21 CFR 868.5795 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EPE clearance
Top EPE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biological & Environmental Control Laboratories | 1 | 1986-11-03 |
| Clinipad Corp. | 1 | 1986-07-15 |
Most recent EPE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863635 | Biological & Environmental Control Laboratories | UPDATED STERILE ENDOTRACHEAL BRUSHES | 1986-11-03 | 47 |
| K862563 | Clinipad Corp. | TRACHEOSTOMY CLEANSING SOLUTION | 1986-07-15 | 12 |
Recalls for EPE devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-23.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code EPE?
EPE is the FDA product code for brush, cleaning, tracheal tube. It is a Class I device, regulated under 21 CFR 868.5795 and reviewed by the Anesthesiology panel.
What device class is EPE?
Class I, regulation 21 CFR 868.5795. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EPE?
Across 2 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most EPE clearances?
Biological & Environmental Control Laboratories (1); Clinipad Corp. (1).
Have EPE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-02-23.
Next steps
- Run an FDA pathway report with predicate devices for product code EPE
- Run a recall and safety report across every EPE manufacturer
- Watch product code EPE 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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