FDA product code JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered
JCX is the FDA product code for apparatus, suction, ward use, portable, ac-powered. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel. FDA has cleared 77 510(k) submissions under JCX, 6 in the last five years, from 52 different applicants. The average 510(k) review took 100 days (median 73); 182 days on average over the last three years. FDA has posted 24 recalls for JCX devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Suction, Ward Use, Portable, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 878.4780 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JCX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 236 |
| 2018 | 2 | 122 |
| 2019 | 3 | 121 |
| 2022 | 1 | 108 |
| 2023 | 1 | 23 |
| 2024 | 1 | 28 |
| 2025 | 2 | 113 |
| 2026 | 1 | 406 |
Compare with all 510(k) review times · Search every JCX clearance
Top JCX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ding Hwa Co., Ltd. | 5 | 2018-07-23 |
| Impact Instrumentation, Inc. | 5 | 2014-03-10 |
| Product & Educational Services | 4 | 1994-05-18 |
| Briox Technologies, Inc. | 4 | 1979-07-24 |
| Dornoch Medical Systems | 3 | 2019-04-24 |
47 more applicants have JCX clearances. See the full list in Caduvo.
Most recent JCX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250964 | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Protable Phlegm Suction Unit (JMA D01) | 2026-05-11 | 406 |
| K243638 | Microvention | MV Flow Aspiration Pump (MVFLOWPMP01) | 2025-06-13 | 200 |
| K251111 | Excitus AS | Cary | 2025-05-07 | 26 |
| K243418 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing | 2024-12-02 | 28 |
| K233428 | Guangzhou Easycess Medical Co.,Ltd | Easycess Aspiration Pump | 2023-11-03 | 23 |
Recalls for JCX devices
24 product recalls in 19 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-05-06.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2020 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code JCX?
JCX is the FDA product code for apparatus, suction, ward use, portable, ac-powered. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel.
What device class is JCX?
Class II, regulation 21 CFR 878.4780. Typical premarket route: 510(k).
How long does a 510(k) take for product code JCX?
Across 77 cleared submissions the average was 100 days from receipt to decision (median 73).
Which companies have the most JCX clearances?
Ding Hwa Co., Ltd. (5); Impact Instrumentation, Inc. (5); Product & Educational Services (4); Briox Technologies, Inc. (4); Dornoch Medical Systems (3).
Have JCX devices been recalled?
Yes: 24 product recalls across 19 recall events; the most recent began 2026-05-06.
Next steps
- Run an FDA pathway report with predicate devices for product code JCX
- Run a recall and safety report across every JCX manufacturer
- Watch product code JCX 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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