FDA product code FMJ: Manometer, Spinal-Fluid
FMJ is the FDA product code for manometer, spinal-fluid. It is a Class II device, regulated under 21 CFR 880.2500 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under FMJ, from 6 different applicants. The average 510(k) review took 82 days (median 58). FDA has posted 5 recalls for FMJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Manometer, Spinal-Fluid |
| Device class | Class II |
| Regulation | 21 CFR 880.2500 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FMJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 175 |
Compare with all 510(k) review times · Search every FMJ clearance
Top FMJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| PAJUNK GmbH Medizintechnologie | 1 | 2017-07-25 |
| Busse Hospital Disposables, Inc. | 1 | 2003-08-28 |
| B.Braun Medical, Inc. | 1 | 1997-04-07 |
| Smiths Industries Medical Systems, Inc. | 1 | 1996-10-18 |
| Megadyne Medical Products, Inc. | 1 | 1991-06-20 |
1 more applicants have FMJ clearances. See the full list in Caduvo.
Most recent FMJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170305 | PAJUNK GmbH Medizintechnologie | Spinal Manometer NRFit; Spinal Manometer LUER | 2017-07-25 | 175 |
| K032432 | Busse Hospital Disposables, Inc. | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER | 2003-08-28 | 22 |
| K970287 | B.Braun Medical, Inc. | LUMBAR PUNCTURE KIT | 1997-04-07 | 73 |
| K963570 | Smiths Industries Medical Systems, Inc. | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) | 1996-10-18 | 43 |
| K910089 | Megadyne Medical Products, Inc. | MEGA LUMBAR PUNCTURE KIT | 1991-06-20 | 162 |
Recalls for FMJ devices
5 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-02-22.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code FMJ?
FMJ is the FDA product code for manometer, spinal-fluid. It is a Class II device, regulated under 21 CFR 880.2500 and reviewed by the General Hospital panel.
What device class is FMJ?
Class II, regulation 21 CFR 880.2500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FMJ?
Across 6 cleared submissions the average was 82 days from receipt to decision (median 58).
Which companies have the most FMJ clearances?
PAJUNK GmbH Medizintechnologie (1); Busse Hospital Disposables, Inc. (1); B.Braun Medical, Inc. (1); Smiths Industries Medical Systems, Inc. (1); Megadyne Medical Products, Inc. (1).
Have FMJ devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2022-02-22.
Next steps
- Run an FDA pathway report with predicate devices for product code FMJ
- Run a recall and safety report across every FMJ manufacturer
- Watch product code FMJ 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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