FDA product code JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
JOM is the FDA product code for plethysmograph, photoelectric, pneumatic or hydraulic. It is a Class II device, regulated under 21 CFR 870.2780 and reviewed by the Cardiovascular panel. FDA has cleared 53 510(k) submissions under JOM, 2 in the last five years, from 40 different applicants. The average 510(k) review took 121 days (median 100).
Classification
| Field | Value |
|---|---|
| Device name | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Device class | Class II |
| Regulation | 21 CFR 870.2780 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JOM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 18 |
| 2018 | 1 | 128 |
| 2020 | 2 | 242 |
| 2021 | 1 | 359 |
| 2022 | 2 | 192 |
Compare with all 510(k) review times · Search every JOM clearance
Top JOM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| D. E. Hokanson, Inc. | 5 | 2003-02-12 |
| Biomedix, Inc. | 3 | 2012-08-29 |
| Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2 | 2020-12-11 |
| Ld Technology, LLC | 2 | 2017-12-19 |
| Medicore Co., Ltd. | 2 | 2011-06-13 |
35 more applicants have JOM clearances. See the full list in Caduvo.
Most recent JOM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220527 | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | PADnet Xpress | 2022-10-20 | 238 |
| K213730 | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | 2022-04-21 | 146 |
| K200567 | Arterial Stiffness, Inc. | ASI Plethysmogrpah Analyzer | 2021-02-26 | 359 |
| K201046 | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | Automated ankle brachial pressure index measuring device, MESI mTABLET system | 2020-12-11 | 234 |
| K191266 | Medeia, Inc. | VitalScan ANS | 2020-01-15 | 250 |
Recalls for JOM devices
openFDA lists no recalls for product code JOM.
Frequently asked questions
What is FDA product code JOM?
JOM is the FDA product code for plethysmograph, photoelectric, pneumatic or hydraulic. It is a Class II device, regulated under 21 CFR 870.2780 and reviewed by the Cardiovascular panel.
What device class is JOM?
Class II, regulation 21 CFR 870.2780. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOM?
Across 53 cleared submissions the average was 121 days from receipt to decision (median 100).
Which companies have the most JOM clearances?
D. E. Hokanson, Inc. (5); Biomedix, Inc. (3); Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. (2); Ld Technology, LLC (2); Medicore Co., Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code JOM
- Run a recall and safety report across every JOM manufacturer
- Watch product code JOM 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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