FDA product code JOP: Transducer, Ultrasonic
JOP is the FDA product code for transducer, ultrasonic. It is a Class II device, regulated under 21 CFR 870.2880 and reviewed by the Cardiovascular panel. FDA has cleared 72 510(k) submissions under JOP, 2 in the last five years, from 38 different applicants. The average 510(k) review took 165 days (median 140); 161 days on average over the last three years. FDA has posted 1 recall for JOP devices.
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 870.2880 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JOP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 2 | 161 |
Top JOP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Technology Laboratories, Inc. | 7 | 1985-03-12 |
| Acuson Computed Sonography | 6 | 1987-09-28 |
| Koven Technology, Inc. | 3 | 2016-05-25 |
| Ge Medical Systems Information Technologies | 3 | 1991-02-11 |
| Interspec, Inc. | 3 | 1989-07-19 |
33 more applicants have JOP clearances. See the full list in Caduvo.
Most recent JOP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242662 | Viasonix , Ltd. | Falcon/Xpress (Falcon/Xpress) | 2024-12-18 | 105 |
| K233976 | Corvascular Diagnostics, LLC | VasoGuard (V10, V8, V6, V4, V2) | 2024-07-19 | 217 |
| K153762 | Koven Technology, Inc. | Smartdop XT6 | 2016-05-25 | 147 |
| K131623 | Koven Technology, Inc. | SMARTDOP XT | 2014-01-17 | 227 |
| K131860 | Us Vascular, LLC | VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING | 2013-09-27 | 95 |
Recalls for JOP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-06-26.
Frequently asked questions
What is FDA product code JOP?
JOP is the FDA product code for transducer, ultrasonic. It is a Class II device, regulated under 21 CFR 870.2880 and reviewed by the Cardiovascular panel.
What device class is JOP?
Class II, regulation 21 CFR 870.2880. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOP?
Across 72 cleared submissions the average was 165 days from receipt to decision (median 140).
Which companies have the most JOP clearances?
Advanced Technology Laboratories, Inc. (7); Acuson Computed Sonography (6); Koven Technology, Inc. (3); Ge Medical Systems Information Technologies (3); Interspec, Inc. (3).
Have JOP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-06-26.
Next steps
- Run an FDA pathway report with predicate devices for product code JOP
- Run a recall and safety report across every JOP manufacturer
- Watch product code JOP 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.