FDA product code BXY: Flowmeter, Calibration, Gas
BXY is the FDA product code for flowmeter, calibration, gas. It is a Class I device, regulated under 21 CFR 868.2350 and reviewed by the Anesthesiology panel. FDA has cleared 7 510(k) submissions under BXY, from 6 different applicants. The average 510(k) review took 37 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Flowmeter, Calibration, Gas |
| Device class | Class I |
| Regulation | 21 CFR 868.2350 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BXY clearance
Top BXY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Precision Medical, Inc. | 2 | 1990-07-23 |
| Westmed Intl. | 1 | 1995-09-15 |
| B&B Medical Technologies, Inc. | 1 | 1986-10-22 |
| Life Support Products, Inc. | 1 | 1986-02-21 |
| Telectronics, Inc. | 1 | 1985-05-10 |
1 more applicants have BXY clearances. See the full list in Caduvo.
Most recent BXY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953506 | Westmed Intl. | WESTMED RESPIRATORY LUER ADAPTOR | 1995-09-15 | 51 |
| K902917 | Precision Medical, Inc. | PRECISION MEDICAL ELIMINATOR | 1990-07-23 | 20 |
| K902916 | Precision Medical, Inc. | PRECISION MEDICAL NEB BLOCK | 1990-07-23 | 20 |
| K863510 | B&B Medical Technologies, Inc. | OXY-OFF(TM) | 1986-10-22 | 43 |
| K860516 | Life Support Products, Inc. | LSP MINILATOR | 1986-02-21 | 10 |
Recalls for BXY devices
openFDA lists no recalls for product code BXY.
Frequently asked questions
What is FDA product code BXY?
BXY is the FDA product code for flowmeter, calibration, gas. It is a Class I device, regulated under 21 CFR 868.2350 and reviewed by the Anesthesiology panel.
What device class is BXY?
Class I, regulation 21 CFR 868.2350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXY?
Across 7 cleared submissions the average was 37 days from receipt to decision (median 29).
Which companies have the most BXY clearances?
Precision Medical, Inc. (2); Westmed Intl. (1); B&B Medical Technologies, Inc. (1); Life Support Products, Inc. (1); Telectronics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXY
- Run a recall and safety report across every BXY manufacturer
- Watch product code BXY 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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