Atlas FDA

JCX

77 FDA 510(k) clearances · Product code

73 daysmedian time to decision
200 days90th percentile
77clearances measured

FDA profile

Official device name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 227 · 2022: 215 · 2023: 187 · 2024: 103 · 2025: 46 · 2026: 58
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Protable Phlegm Suction Unit (JMA D01) (K250964)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.2026-05-11
MV Flow Aspiration Pump (MVFLOWPMP01) (K243638)Microvention2025-06-13
Cary (K251111)Excitus AS2025-05-07
Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (K243418)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2024-12-02
Easycess Aspiration Pump (K233428)Guangzhou Easycess Medical Co.,Ltd2023-11-03
120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) (K222552)Stryker Instruments2022-12-09
Acare Suction Unit (K182950)Acare Technology Co., Ltd.2019-08-23
IntelliCartTM System (K190789)Dornoch Medical Systems2019-04-24
ZOOM Aspiration Pump (K190105)Taiwan Biomaterial Co., Ltd.2019-02-21
TWBM Pump (K180115)Taiwan Biomaterial Co., Ltd.2018-07-24
DV-300 Aspirator (K181398)Ding Hwa Co., Ltd.2018-07-23
IntelliCart System (K172481)Dornoch Medical Systems2017-09-14
Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds (K161358)Surgical Instrument Service and Savings, Inc.2017-08-03
IntelliCartTM System (K162421)Dornoch Medical Systems2016-12-21
Stryker Neptune 3 Waste Management System (K153407)Stryker Corporation2016-04-25
CLIQ DV-300 ASPIRATOR (K140809)Ding Hwa Co., Ltd.2014-06-23
SUCTION PUMP (K140031)Ding Hwa Co., Ltd.2014-04-28
DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID (K133786)Dornoch Medical Systems, Inc.2014-03-21
IMPACT MODEL 323 ASPIRATOR (K133196)Impact Instrumentation, Inc.2014-03-10
CLIQ DV-300 ASPIRATOR (K132308)Ding Hwa Co., Ltd.2013-12-30
STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM (K132671)Stryker Corporation2013-12-20
CARE SU01A SUCTION ASPIRATOR (K130001)Foshan Care Medical Technology Co., Ltd.2013-07-25
AG MASS (K131099)Hospitech Respiration , Ltd.2013-05-13
DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC (K123188)Dornoch Medical Systems, Inc.2013-03-04
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING (K122756)Penumbra, Inc.2012-10-02
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES (K120065)Plaxtron Industrial (M) Sdn. Bhd.2012-04-03
EMG SUCTION UNIT (K112421)Emg Technology Co., Ltd.2011-09-01
VACPLUS SUCTION UNIT (K103535)Apex Medical Corp.2011-02-24
VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 (K102626)Vega Technologies, Inc.2010-11-12
BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM (K090759)Biodrain Medical, Inc.2009-04-01
AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE (K082762)Aardvark Medical2008-11-12
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM (K080845)Cardinalhealth2008-04-30
TRANSPOSAL ULTRA SYSTEMS (K081047)Dornoch Medical Systems, Inc.2008-04-29
SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 (K080005)Ding Hwa Co., Ltd.2008-04-24
EMG AC/DC SUCTION UNIT (K063448)Emg Technology Co., Ltd.2006-11-30
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (K060277)Boehringer Laboratories2006-03-03
EMG MODEL SUA01 SUCTION UNIT (K042349)Emg Technology Co., Ltd.2004-12-16
OLYMPUS SUCTION PUMP, MODEL KV-5 (K011725)Keymed (Medical & Industrial Equipment), Ltd.2001-08-31
REDON SET (K001716)Pfm Produkte Fur Die Medizin AG2000-07-19
DEVILBISS SUCTION UNIT (K982304)Sunrise Medical Hhg, Inc.1998-09-25
THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT (K974038)A & A Medical, Inc.1998-05-11
CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR (K963558)Contemporary Products, Inc.1996-12-04
LSU 2000 PORTABLE SUCTION UNIT (K950698)Laerdal Medical Corp.1995-05-09
VACPLUS (K945062)Kinetic Concepts, Inc.1995-03-14
SURE-FLO IRRIGATION Y TUBING SET (K944119)O.R. Resources, Inc.1994-12-05
ANNELID (K940886)Kinetic Concepts, Inc.1994-11-17
MODEL 2300 GENERAL PURPOSE SUCTION PUMP (K941527)Product & Educational Services1994-05-18
MODEL 2200 THORACIC SUCTION PUMP (K941525)Product & Educational Services1994-05-18
MODEL 2000 MILD INTERMITTENT SUCTION PUMP (K941526)Product & Educational Services1994-05-18
MODEL 2100 MILD INTERMITTENT SUCTION PUMP (K941524)Product & Educational Services1994-05-17
SCHUCO-VAC MODEL 178 (K935218)Schuco, Inc.1994-04-05
OLYMPUS SUCTION PUMP MODEL KV-4 (K930852)Keymed (Medical & Industrial Equipment), Ltd.1994-03-31
SUCTION TUBES: HOUSE, BARON (K930030)Thomasville Medical Assoc.1994-02-25
COOK ASPIRATION UNIT (K930900)Cook Ob/Gyn1993-07-22
POWERED VACUUM ASPIRATOR 1110-G-030 (K920287)Stirn Industries1992-06-29
POWERED VACUUM ASPIRATOR 1110-G-062 (K920288)Stirn Industries1992-06-29
STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU (K914694)Depuy, Inc.1992-01-16
HYDRODISECTOR (K914177)Spiess Design, Inc.1991-11-29
IRRIGATION AND SUCTION APPARATUS (K900430)Acorn Group, Inc.1990-06-05
GENERAL ASPERATOR (K895761)Kolster Methods1989-10-18
VACU-AIDE (K872094)The Devilbiss Co.1987-10-15
TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT (K843081)Creative Medical Laboratories, Inc.1984-10-11
IMPACT MODEL 316 (K842050)Impact Instrumentation, Inc.1984-08-03
IMPACT MODEL 308 (K841538)Impact Instrumentation, Inc.1984-06-11
MORWEL ASPIRATOR (K841160)Morwel Corp.1984-05-31
DIRECT BONDED BRACKET REMOVER (K832301)Northwest Orthopedics1983-08-31
IMPACT, MODEL 302 (K820331)Impact Instrumentation, Inc.1982-02-23
IMPACT, MODEL E-12 (K820330)Impact Instrumentation, Inc.1982-02-23
LOSEFF BALLOON TYPE SELF-RETENTION WOUND (K801349)Loseff Medical Designers, Ltd.1980-08-07
E-VAX CHEST DRAINAGE SYSTEM (K801043)Cardio Surgical Concepts, Inc.1980-06-20
AMBU UNIVERSAL SUCTION PUMP (K792592)Narco Air-Shields1980-01-11
BRIOX MODEL 2000-CA COMPRESSOR UNIT (K791241)Briox Technologies, Inc.1979-07-24
PORTABLE ASPIRATOR (K791210)Sam Say Assoc.1979-07-24
BRIOX MODEL 2000-A ASPIRATOR UNIT (K791239)Briox Technologies, Inc.1979-07-24
BRIOX MODEL 2000-C COMPRESSOR UNIT (K791240)Briox Technologies, Inc.1979-07-24
BRIOX MODEL 2000-CQ QUIET COMPRESSOR (K791238)Briox Technologies, Inc.1979-07-24
PORTO-VAC (K771071)Cpac, Inc.1977-07-14

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Every clearance here is in the API, with alerts when new ones post.