Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JCX — Predicate Candidate Screening
77 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
200 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250964 | Protable Phlegm Suction Unit (JMA D01) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2026-05-11 | 406 | 0 |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | Microvention | 2025-06-13 | 200 | 0 |
| K251111 | Cary | Excitus AS | 2025-05-07 | 26 | 0 |
| K243418 | Riptide™ Aspiration Pump; Riptide™ Collection Canister with | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-12-02 | 28 | 0 |
| K233428 | Easycess Aspiration Pump | Guangzhou Easycess Medical Co.,Ltd | 2023-11-03 | 23 | 0 |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750 | Stryker Instruments | 2022-12-09 | 108 | 0 |
| K182950 | Acare Suction Unit | Acare Technology Co., Ltd. | 2019-08-23 | 304 | 0 |
| K190789 | IntelliCartTM System | Dornoch Medical Systems | 2019-04-24 | 28 | 0 |
| K190105 | ZOOM Aspiration Pump | Taiwan Biomaterial Co., Ltd. | 2019-02-21 | 30 | 0 |
| K180115 | TWBM Pump | Taiwan Biomaterial Co., Ltd. | 2018-07-24 | 189 | 0 |
| K181398 | DV-300 Aspirator | Ding Hwa Co., Ltd. | 2018-07-23 | 55 | 0 |
| K172481 | IntelliCart System | Dornoch Medical Systems | 2017-09-14 | 29 | 0 |
| K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Surgical Instrument Service and Savings, Inc. | 2017-08-03 | 444 | 0 |
| K162421 | IntelliCartTM System | Dornoch Medical Systems | 2016-12-21 | 113 | 0 |
| K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | 2016-04-25 | 152 | 1 |
| K140809 | CLIQ DV-300 ASPIRATOR | Ding Hwa Co., Ltd. | 2014-06-23 | 83 | 0 |
| K140031 | SUCTION PUMP | Ding Hwa Co., Ltd. | 2014-04-28 | 112 | 0 |
| K133786 | DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOC | Dornoch Medical Systems, Inc. | 2014-03-21 | 99 | 0 |
| K133196 | IMPACT MODEL 323 ASPIRATOR | Impact Instrumentation, Inc. | 2014-03-10 | 144 | 0 |
| K132308 | CLIQ DV-300 ASPIRATOR | Ding Hwa Co., Ltd. | 2013-12-30 | 158 | 0 |
| K132671 | STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM | Stryker Corporation | 2013-12-20 | 115 | 5 |
| K130001 | CARE SU01A SUCTION ASPIRATOR | Foshan Care Medical Technology Co., Ltd. | 2013-07-25 | 204 | 0 |
| K131099 | AG MASS | Hospitech Respiration , Ltd. | 2013-05-13 | 24 | 0 |
| K123188 | DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DO | Dornoch Medical Systems, Inc. | 2013-03-04 | 144 | 0 |
| K122756 | PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENU | Penumbra, Inc. | 2012-10-02 | 25 | 0 |
| K120065 | PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES | Plaxtron Industrial (M) Sdn. Bhd. | 2012-04-03 | 85 | 1 |
| K112421 | EMG SUCTION UNIT | Emg Technology Co., Ltd. | 2011-09-01 | 9 | 0 |
| K103535 | VACPLUS SUCTION UNIT | Apex Medical Corp. | 2011-02-24 | 85 | 0 |
| K102626 | VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 | Vega Technologies, Inc. | 2010-11-12 | 60 | 0 |
| K090759 | BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM | Biodrain Medical, Inc. | 2009-04-01 | 9 | 0 |
| K082762 | AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE | Aardvark Medical | 2008-11-12 | 51 | 0 |
| K080845 | ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM | Cardinalhealth | 2008-04-30 | 35 | 0 |
| K081047 | TRANSPOSAL ULTRA SYSTEMS | Dornoch Medical Systems, Inc. | 2008-04-29 | 15 | 0 |
| K080005 | SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 | Ding Hwa Co., Ltd. | 2008-04-24 | 113 | 0 |
| K063448 | EMG AC/DC SUCTION UNIT | Emg Technology Co., Ltd. | 2006-11-30 | 15 | 0 |
| K060277 | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM | Boehringer Laboratories | 2006-03-03 | 29 | 0 |
| K042349 | EMG MODEL SUA01 SUCTION UNIT | Emg Technology Co., Ltd. | 2004-12-16 | 108 | 1 |
| K011725 | OLYMPUS SUCTION PUMP, MODEL KV-5 | Keymed (Medical & Industrial Equipment), Ltd. | 2001-08-31 | 88 | 0 |
| K001716 | REDON SET | Pfm Produkte Fur Die Medizin AG | 2000-07-19 | 44 | 0 |
| K982304 | DEVILBISS SUCTION UNIT | Sunrise Medical Hhg, Inc. | 1998-09-25 | 86 | 3 |
| K974038 | THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GL | A & A Medical, Inc. | 1998-05-11 | 199 | 0 |
| K963558 | CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR | Contemporary Products, Inc. | 1996-12-04 | 90 | 0 |
| K950698 | LSU 2000 PORTABLE SUCTION UNIT | Laerdal Medical Corp. | 1995-05-09 | 88 | 0 |
| K945062 | VACPLUS | Kinetic Concepts, Inc. | 1995-03-14 | 151 | 0 |
| K944119 | SURE-FLO IRRIGATION Y TUBING SET | O.R. Resources, Inc. | 1994-12-05 | 104 | 0 |
| K940886 | ANNELID | Kinetic Concepts, Inc. | 1994-11-17 | 265 | 0 |
| K941527 | MODEL 2300 GENERAL PURPOSE SUCTION PUMP | Product & Educational Services | 1994-05-18 | 49 | 0 |
| K941525 | MODEL 2200 THORACIC SUCTION PUMP | Product & Educational Services | 1994-05-18 | 49 | 0 |
| K941526 | MODEL 2000 MILD INTERMITTENT SUCTION PUMP | Product & Educational Services | 1994-05-18 | 49 | 0 |
| K941524 | MODEL 2100 MILD INTERMITTENT SUCTION PUMP | Product & Educational Services | 1994-05-17 | 48 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda