FDA product code JEH: Plethysmograph, Volume
JEH is the FDA product code for plethysmograph, volume. It is a Class II device, regulated under 21 CFR 868.1760 and reviewed by the Anesthesiology panel. FDA has cleared 11 510(k) submissions under JEH, 2 in the last five years, from 10 different applicants. The average 510(k) review took 229 days (median 218); 270 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Plethysmograph, Volume |
| Device class | Class II |
| Regulation | 21 CFR 868.1760 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JEH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 155 |
| 2024 | 1 | 270 |
Compare with all 510(k) review times · Search every JEH clearance
Top JEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Erich Jaeger GmbH & Co. KG | 2 | 1995-07-31 |
| Ganshorn Medizin Electronic GmbH | 1 | 2024-12-09 |
| Vitalograph Ireland, Ltd. | 1 | 2023-05-25 |
| Viasys Healthcare GmbH | 1 | 2008-04-22 |
| Morgan Scientific, Inc. | 1 | 2003-01-13 |
5 more applicants have JEH clearances. See the full list in Caduvo.
Most recent JEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240706 | Ganshorn Medizin Electronic GmbH | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | 2024-12-09 | 270 |
| K223818 | Vitalograph Ireland, Ltd. | Model 9160 VitaloQUB | 2023-05-25 | 155 |
| K072061 | Viasys Healthcare GmbH | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | 2008-04-22 | 270 |
| K022636 | Morgan Scientific, Inc. | BODY BOX 5500 | 2003-01-13 | 158 |
| K960840 | C.E. Diagnosis, Inc. | C.E. VASCULAR MACHINE | 1997-03-28 | 393 |
Recalls for JEH devices
openFDA lists no recalls for product code JEH.
Frequently asked questions
What is FDA product code JEH?
JEH is the FDA product code for plethysmograph, volume. It is a Class II device, regulated under 21 CFR 868.1760 and reviewed by the Anesthesiology panel.
What device class is JEH?
Class II, regulation 21 CFR 868.1760. Typical premarket route: 510(k).
How long does a 510(k) take for product code JEH?
Across 11 cleared submissions the average was 229 days from receipt to decision (median 218).
Which companies have the most JEH clearances?
Erich Jaeger GmbH & Co. KG (2); Ganshorn Medizin Electronic GmbH (1); Vitalograph Ireland, Ltd. (1); Viasys Healthcare GmbH (1); Morgan Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JEH
- Run a recall and safety report across every JEH manufacturer
- Watch product code JEH 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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