FDA product code CAR: Monitor, Spinal-Fluid Pressure, Electrically Powered
CAR is the FDA product code for monitor, spinal-fluid pressure, electrically powered. It is a Class II device, regulated under 21 CFR 880.2460 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under CAR, from 3 different applicants. The average 510(k) review took 344 days (median 196).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Spinal-Fluid Pressure, Electrically Powered |
| Device class | Class II |
| Regulation | 21 CFR 880.2460 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CAR clearance
Top CAR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Industrias Palex C/O Dma Med-Chem Corp. | 1 | 1994-03-07 |
| Bion Ent., Ltd. | 1 | 1993-06-15 |
| Impra, Inc. | 1 | 1992-03-11 |
Most recent CAR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920740 | Industrias Palex C/O Dma Med-Chem Corp. | EPISENSOR PLUS | 1994-03-07 | 747 |
| K926066 | Bion Ent., Ltd. | BION MUMPS-G ANTIBODY TEST SYSTEM | 1993-06-15 | 196 |
| K915577 | Impra, Inc. | IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE | 1992-03-11 | 89 |
Recalls for CAR devices
openFDA lists no recalls for product code CAR.
Frequently asked questions
What is FDA product code CAR?
CAR is the FDA product code for monitor, spinal-fluid pressure, electrically powered. It is a Class II device, regulated under 21 CFR 880.2460 and reviewed by the General Hospital panel.
What device class is CAR?
Class II, regulation 21 CFR 880.2460. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAR?
Across 3 cleared submissions the average was 344 days from receipt to decision (median 196).
Which companies have the most CAR clearances?
Industrias Palex C/O Dma Med-Chem Corp. (1); Bion Ent., Ltd. (1); Impra, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CAR
- Run a recall and safety report across every CAR manufacturer
- Watch product code CAR 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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