JCXClass II
Apparatus, Suction, Ward Use, Portable, Ac-Powered
21 CFR 878.4780 / General, Plastic Surgery
JCX is the FDA product code for Apparatus, Suction, Ward Use, Portable, Ac-Powered, a class II device type, regulated under 21 CFR 878.4780. As of , FDA records hold 77 510(k) clearances under this code, the most recent dated , and 24 recalls.
Classification record
- Product code
- JCX
- Device name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Regulation
- 21 CFR 878.4780
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 77
- Ingested recalls
- 24
Clearances, product code JCX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 5 |
| 1980 | 3 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 4 |
| 1987 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 9 |
| 1995 | 2 |
| 1996 | 1 |
| 1998 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2004 | 1 |
| 2006 | 2 |
| 2008 | 4 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 5 |
| 2014 | 4 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code JCX| Applicant | Clearances |
|---|---|
| Dornoch Medical Systems | 6 |
| Ding Hwa Co., Ltd. | 5 |
| ZOLL Medical Corporation | 5 |
| Briox Technologies, Inc. | 4 |
| Product & Educational Services | 4 |
| EMG Technology Co., Ltd. | 3 |
| Stryker Corp. | 3 |
| KEYMED (Medical & Industrial Equipment) Ltd | 2 |
| KCI USA, Inc. | 2 |
| Stirn Industries | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Acare Technology Co., Ltd.
- AD Supply Group Limited
- Allied Medical LLC
- Anest Iwata Sparmax Co., Ltd.
- Black & Black Surgical, Inc.
- Canadian Hospital Specialties Ltd.
- Compass Health Brands (Corporate Office)
- CPAC Equipment, Inc.
- DeRoyal Industries, Inc.
- EMG Technology Co., Ltd.
- Foshan Care Medical Technology Co., Ltd.
- Hospitech Respiration
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
