FDA product code BTP: Dropper, Ether
BTP is the FDA product code for dropper, ether. It is a Class I device, regulated under 21 CFR 868.5420 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under BTP. The average 510(k) review took 151 days (median 151).
Classification
| Field | Value |
|---|---|
| Device name | Dropper, Ether |
| Device class | Class I |
| Regulation | 21 CFR 868.5420 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every BTP clearance
Top BTP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hospitech Respiration , Ltd. | 1 | 2010-03-02 |
Most recent BTP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093126 | Hospitech Respiration , Ltd. | ANAPNOGUARD ENDOTRACHEAL TUBE | 2010-03-02 | 151 |
Recalls for BTP devices
openFDA lists no recalls for product code BTP.
Frequently asked questions
What is FDA product code BTP?
BTP is the FDA product code for dropper, ether. It is a Class I device, regulated under 21 CFR 868.5420 and reviewed by the Anesthesiology panel.
What device class is BTP?
Class I, regulation 21 CFR 868.5420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BTP?
Across 1 cleared submissions the average was 151 days from receipt to decision (median 151).
Which companies have the most BTP clearances?
Hospitech Respiration , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BTP
- Run a recall and safety report across every BTP manufacturer
- Watch product code BTP 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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