FDA product code BXH: Gauge, Gas Pressure, Cylinder/Pipeline
BXH is the FDA product code for gauge, gas pressure, cylinder/pipeline. It is a Class I device, regulated under 21 CFR 868.2610 and reviewed by the Anesthesiology panel. FDA has cleared 4 510(k) submissions under BXH, from 4 different applicants. The average 510(k) review took 45 days (median 44). FDA has posted 1 recall for BXH devices.
Classification
| Field | Value |
|---|---|
| Device name | Gauge, Gas Pressure, Cylinder/Pipeline |
| Device class | Class I |
| Regulation | 21 CFR 868.2610 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Top BXH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| B & F Medical Products, Inc. | 1 | 1994-07-27 |
| Erie Medical | 1 | 1985-10-10 |
| Hospitak, Inc. | 1 | 1984-09-19 |
| Dynatech Cryomedical Co. | 1 | 1977-04-07 |
Most recent BXH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942645 | B & F Medical Products, Inc. | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG | 1994-07-27 | 54 |
| K853040 | Erie Medical | PRESSURE GAUGE | 1985-10-10 | 83 |
| K843212 | Hospitak, Inc. | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | 1984-09-19 | 35 |
| K770614 | Dynatech Cryomedical Co. | MONITOR, GAS MANIFOLD | 1977-04-07 | 7 |
Recalls for BXH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-12-02.
Frequently asked questions
What is FDA product code BXH?
BXH is the FDA product code for gauge, gas pressure, cylinder/pipeline. It is a Class I device, regulated under 21 CFR 868.2610 and reviewed by the Anesthesiology panel.
What device class is BXH?
Class I, regulation 21 CFR 868.2610. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXH?
Across 4 cleared submissions the average was 45 days from receipt to decision (median 44).
Which companies have the most BXH clearances?
B & F Medical Products, Inc. (1); Erie Medical (1); Hospitak, Inc. (1); Dynatech Cryomedical Co. (1).
Have BXH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-12-02.
Next steps
- Run an FDA pathway report with predicate devices for product code BXH
- Run a recall and safety report across every BXH manufacturer
- Watch product code BXH 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.