FDA product code JAF: Monitor, Ultrasonic, Nonfetal
JAF is the FDA product code for monitor, ultrasonic, nonfetal. It is a Class II device, regulated under 21 CFR 892.1540 and reviewed by the Radiology panel. FDA has cleared 38 510(k) submissions under JAF, 1 in the last five years, from 27 different applicants. The average 510(k) review took 140 days (median 92); 114 days on average over the last three years. FDA has posted 8 recalls for JAF devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Ultrasonic, Nonfetal |
| Device class | Class II |
| Regulation | 21 CFR 892.1540 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JAF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 114 |
Compare with all 510(k) review times · Search every JAF clearance
Top JAF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thd Spa | 3 | 2015-02-24 |
| Imex Medical Systems, Inc. | 3 | 1998-02-05 |
| Summit Doppler Systems, Inc. | 2 | 2009-12-24 |
| Nicolet Biomedical | 2 | 2001-03-09 |
| Biomedix, Inc. | 2 | 1997-12-29 |
22 more applicants have JAF clearances. See the full list in Caduvo.
Most recent JAF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242487 | Laminar Digital Health, Inc. | Laminar P1 (LDH-HW-001) | 2024-12-13 | 114 |
| K141657 | Thd Spa | THD REVOLUTION | 2015-02-24 | 249 |
| K110628 | Newman Medical | SIMPLEABI | 2011-05-12 | 70 |
| K093393 | Summit Doppler Systems, Inc. | LIFEDOP MODEL 300ABI | 2009-12-24 | 55 |
| K090009 | Thd Spa | THD SLIDE ONE | 2009-01-28 | 26 |
Recalls for JAF devices
8 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-02-10.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2023 | 4 |
Frequently asked questions
What is FDA product code JAF?
JAF is the FDA product code for monitor, ultrasonic, nonfetal. It is a Class II device, regulated under 21 CFR 892.1540 and reviewed by the Radiology panel.
What device class is JAF?
Class II, regulation 21 CFR 892.1540. Typical premarket route: 510(k).
How long does a 510(k) take for product code JAF?
Across 38 cleared submissions the average was 140 days from receipt to decision (median 92).
Which companies have the most JAF clearances?
Thd Spa (3); Imex Medical Systems, Inc. (3); Summit Doppler Systems, Inc. (2); Nicolet Biomedical (2); Biomedix, Inc. (2).
Have JAF devices been recalled?
Yes: 8 product recalls across 2 recall events; the most recent began 2023-02-10.
Next steps
- Run an FDA pathway report with predicate devices for product code JAF
- Run a recall and safety report across every JAF manufacturer
- Watch product code JAF 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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