FDA product code BXR: Meter, Airway Pressure (Inspiratory Force)
BXR is the FDA product code for meter, airway pressure (inspiratory force). It is a Class II device, regulated under 21 CFR 868.1780 and reviewed by the Anesthesiology panel. FDA has cleared 6 510(k) submissions under BXR, from 6 different applicants. The average 510(k) review took 135 days (median 127).
Classification
| Field | Value |
|---|---|
| Device name | Meter, Airway Pressure (Inspiratory Force) |
| Device class | Class II |
| Regulation | 21 CFR 868.1780 |
| 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 BXR clearance
Top BXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Industries, Inc. | 1 | 2008-09-11 |
| Mercury Medical | 1 | 2004-02-03 |
| Warren E. Collins, Inc. | 1 | 1992-01-15 |
| Thayer Medical Corp. | 1 | 1991-01-28 |
| Medical Support Products, Inc. | 1 | 1990-07-25 |
1 more applicants have BXR clearances. See the full list in Caduvo.
Most recent BXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081693 | Instrumentation Industries, Inc. | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | 2008-09-11 | 86 |
| K032593 | Mercury Medical | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER | 2004-02-03 | 165 |
| K912946 | Warren E. Collins, Inc. | COLLINS DIGITAL PULMONARY MANOMETER | 1992-01-15 | 194 |
| K904917 | Thayer Medical Corp. | THAYER MIP ADAPTER | 1991-01-28 | 89 |
| K901998 | Medical Support Products, Inc. | DIGITAL MANOMETER (DM 50) | 1990-07-25 | 84 |
Recalls for BXR devices
openFDA lists no recalls for product code BXR.
Frequently asked questions
What is FDA product code BXR?
BXR is the FDA product code for meter, airway pressure (inspiratory force). It is a Class II device, regulated under 21 CFR 868.1780 and reviewed by the Anesthesiology panel.
What device class is BXR?
Class II, regulation 21 CFR 868.1780. Typical premarket route: 510(k).
How long does a 510(k) take for product code BXR?
Across 6 cleared submissions the average was 135 days from receipt to decision (median 127).
Which companies have the most BXR clearances?
Instrumentation Industries, Inc. (1); Mercury Medical (1); Warren E. Collins, Inc. (1); Thayer Medical Corp. (1); Medical Support Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXR
- Run a recall and safety report across every BXR manufacturer
- Watch product code BXR 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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