FDA product code BSE: Analyzer, Gas, Helium, Gaseous-Phase
BSE is the FDA product code for analyzer, gas, helium, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1640 and reviewed by the Anesthesiology panel. FDA has cleared 3 510(k) submissions under BSE, from 3 different applicants. The average 510(k) review took 87 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Helium, Gaseous-Phase |
| Device class | Class II |
| Regulation | 21 CFR 868.1640 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every BSE clearance
Top BSE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Associated Services, Inc. | 1 | 1991-01-03 |
| Erich Jaeger, Inc. | 1 | 1984-12-04 |
| Datamed, Inc. | 1 | 1984-07-11 |
Most recent BSE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903939 | Medical Associated Services, Inc. | PANDA HELIUM GAS ANALYZER | 1991-01-03 | 129 |
| K843843 | Erich Jaeger, Inc. | HE TEST | 1984-12-04 | 64 |
| K841858 | Datamed, Inc. | SPIROLOOP | 1984-07-11 | 68 |
Recalls for BSE devices
openFDA lists no recalls for product code BSE.
Frequently asked questions
What is FDA product code BSE?
BSE is the FDA product code for analyzer, gas, helium, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1640 and reviewed by the Anesthesiology panel.
What device class is BSE?
Class II, regulation 21 CFR 868.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code BSE?
Across 3 cleared submissions the average was 87 days from receipt to decision (median 68).
Which companies have the most BSE clearances?
Medical Associated Services, Inc. (1); Erich Jaeger, Inc. (1); Datamed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BSE
- Run a recall and safety report across every BSE manufacturer
- Watch product code BSE 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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