FDA product code JEA: Table, Surgical With Orthopedic Accessories, Ac-Powered
JEA is the FDA product code for table, surgical with orthopedic accessories, ac-powered. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General and Plastic Surgery panel. FDA has cleared 10 510(k) submissions under JEA, from 6 different applicants. The average 510(k) review took 71 days (median 36). FDA has posted 41 recalls for JEA devices, 14 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Table, Surgical With Orthopedic Accessories, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 878.4960 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JEA clearance
Top JEA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Andronic Devices, Ltd. | 4 | 1991-04-29 |
| Orthopedic Systems, Inc. | 2 | 1991-05-21 |
| Stryker Instruments | 1 | 1995-08-08 |
| Mend Technologies, Inc. | 1 | 1993-03-30 |
| Skytron, Div. the Kmw Group, Inc. | 1 | 1990-02-20 |
1 more applicants have JEA clearances. See the full list in Caduvo.
Most recent JEA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953071 | Stryker Instruments | STRYKER COMMAND2 OFFICE CONSOLE | 1995-08-08 | 39 |
| K924094 | Mend Technologies, Inc. | MEND APC | 1993-03-30 | 229 |
| K910736 | Orthopedic Systems, Inc. | JACKSON MULTIPURPOSE OPERATING TABLE | 1991-05-21 | 89 |
| K911522 | Andronic Devices, Ltd. | ARTHROBOT(TM) WRIST HOLDER ACCESSORY | 1991-04-29 | 25 |
| K900290 | Skytron, Div. the Kmw Group, Inc. | SKYTRON MODEL 1100 AND MODEL 142 | 1990-02-20 | 29 |
Recalls for JEA devices
41 product recalls in 15 recall events; 14 initiated in the last five years and 14 still open. Most recent: 2025-02-25.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
| 2024 | 8 |
| 2025 | 6 |
Frequently asked questions
What is FDA product code JEA?
JEA is the FDA product code for table, surgical with orthopedic accessories, ac-powered. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General and Plastic Surgery panel.
What device class is JEA?
Class I, regulation 21 CFR 878.4960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JEA?
Across 10 cleared submissions the average was 71 days from receipt to decision (median 36).
Which companies have the most JEA clearances?
Andronic Devices, Ltd. (4); Orthopedic Systems, Inc. (2); Stryker Instruments (1); Mend Technologies, Inc. (1); Skytron, Div. the Kmw Group, Inc. (1).
Have JEA devices been recalled?
Yes: 41 product recalls across 15 recall events; the most recent began 2025-02-25.
Next steps
- Run an FDA pathway report with predicate devices for product code JEA
- Run a recall and safety report across every JEA manufacturer
- Watch product code JEA 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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