FDA product code JJM: Osmometer For Clinical Use
JJM is the FDA product code for osmometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2730 and reviewed by the Clinical Chemistry panel. FDA has cleared 12 510(k) submissions under JJM, from 5 different applicants. The average 510(k) review took 77 days (median 68). FDA has posted 3 recalls for JJM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Osmometer For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2730 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJM clearance
Top JJM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Instruments, Inc. | 7 | 1997-02-20 |
| Wescor, Inc. | 2 | 1984-03-30 |
| bioMerieux, Inc. | 1 | 1984-10-31 |
| Kyoto Diagnostics, Inc. | 1 | 1984-08-17 |
| Fiske Med Science | 1 | 1981-05-15 |
Most recent JJM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K965036 | Advanced Instruments, Inc. | THE ADVANCED OSMOMETER (3900) | 1997-02-20 | 65 |
| K962056 | Advanced Instruments, Inc. | ADVANCED MICRO-OSMOMETER MODEL 3300 | 1996-07-11 | 44 |
| K925970 | Advanced Instruments, Inc. | MODEL 3D3 OSMOMETER | 1993-07-09 | 226 |
| K911092 | Advanced Instruments, Inc. | OSMOMETER MODEL 2400 | 1991-05-22 | 72 |
| K873642 | Advanced Instruments, Inc. | OSMOMETER MODEL 110 | 1987-10-20 | 41 |
Recalls for JJM devices
3 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-03-11.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code JJM?
JJM is the FDA product code for osmometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2730 and reviewed by the Clinical Chemistry panel.
What device class is JJM?
Class I, regulation 21 CFR 862.2730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJM?
Across 12 cleared submissions the average was 77 days from receipt to decision (median 68).
Which companies have the most JJM clearances?
Advanced Instruments, Inc. (7); Wescor, Inc. (2); bioMerieux, Inc. (1); Kyoto Diagnostics, Inc. (1); Fiske Med Science (1).
Have JJM devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2024-03-11.
Next steps
- Run an FDA pathway report with predicate devices for product code JJM
- Run a recall and safety report across every JJM manufacturer
- Watch product code JJM 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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