JCX · Class II · 21 CFR 878.4780

FDA Product Code JCX: Apparatus, Suction, Ward Use, Portable, Ac-powered

Leading manufacturers include Taiwan Biomaterial Co., Ltd., Acare Technology Co., Ltd. and Dornoch Medical Systems.

77
Total
77
Cleared
100d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 165d recently vs 96d historically

FDA 510(k) Cleared Apparatus, Suction, Ward Use, Portable, Ac-powered Devices (Product Code JCX)

77 devices
1–24 of 77
Cleared May 11, 2026
Protable Phlegm Suction Unit (JMA D01)
K250964
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
General & Plastic Surgery · 406d
Cleared Jun 13, 2025
MV Flow Aspiration Pump (MVFLOWPMP01)
K243638
Microvention
General & Plastic Surgery · 200d
Cleared May 07, 2025
Cary
K251111
Excitus AS
General & Plastic Surgery · 26d
Cleared Dec 02, 2024
Riptide™ Aspiration Pump
K243418
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
General & Plastic Surgery · 28d
Cleared Nov 03, 2023
Easycess Aspiration Pump
K233428
Guangzhou Easycess Medical Co.,Ltd
General & Plastic Surgery · 23d
Cleared Dec 09, 2022
120V Neptune S Rover (0711-001-000)
K222552
Stryker Instruments
General & Plastic Surgery · 108d
Cleared Aug 23, 2019
Acare Suction Unit
K182950
Acare Technology Co., Ltd.
General & Plastic Surgery · 304d
Cleared Apr 24, 2019
IntelliCartTM System
K190789
Dornoch Medical Systems
General & Plastic Surgery · 28d
Cleared Feb 21, 2019
ZOOM Aspiration Pump
K190105
Taiwan Biomaterial Co., Ltd.
General & Plastic Surgery · 30d
Cleared Jul 24, 2018
TWBM Pump
K180115
Taiwan Biomaterial Co., Ltd.
General & Plastic Surgery · 189d
Cleared Jul 23, 2018
DV-300 Aspirator
K181398
Ding Hwa Co., Ltd.
General & Plastic Surgery · 55d
Cleared Jan 16, 1992
STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU
K914694
Depuy, Inc.
General & Plastic Surgery · 90d

About Product Code JCX - Regulatory Context

510(k) Submission Activity

77 total 510(k) submissions under product code JCX since 1977, with 77 receiving FDA clearance (average review time: 100 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JCX Product Code

Recent submissions under JCX have taken an average of 165 days to reach a decision - up from 96 days historically. Manufacturers should account for longer review timelines in current project planning.

JCX devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →