Atlas FDA

MAV

57 FDA 510(k) clearances · Product code

107 daysmedian time to decision
235 days90th percentile
57clearances measured

FDA profile

Official device name
Syringe, Balloon Inflation
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1650
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 186 · 2022: 437 · 2023: 220 · 2024: 421 · 2025: 66 · 2026: 36
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
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) (K220773)Medtronic Vascular2022-04-13
Fluent inflation device (K162272)Vascular Solutions, Inc.2016-10-20
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit (K153038)Medtronic, Inc.2016-04-13
basixTOUCH40 Inflation Syringe (K153672)Merit Medical Systems, Inc.2016-01-20
Fluent Inflation Device (K152387)Vascular Solutions, Inc.2015-12-18
MASTRO PLUS BALLOON IN-DEFLATION DEVICE (K140943)Beijing Demax Medical Technology Co.,Ltd2015-03-05
Presto Inflation Device (K143522)C.R. Bard, Inc.2015-01-12
SUMMED INFLATION DEVICE KIT (K133795)Sunny Medical Device (Shenzhen) Co., Ltd.2014-12-12
ENCORE 26 ADVANTAGE KIT (K140745)Boston Scientific Corp2014-04-17
BASIXTOUCH (K130566)Merit Medical Systems, Inc.2013-06-19
BASIXCONPAK ANALOG INFLATION SYRINGE (K122321)Merit Medical Ireland, Ltd.2012-12-19
OXTI INFLATION DEVICE (K122152)Oxti Corporation2012-12-14
ENCORE 26 ADVANTAGE KIT (K123214)Boston Scientific Corp2012-11-13
ENCORE 26 ADVANTAGE KIT (K120694)Boston Scientific Corp2012-04-03
ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK (K102648)Shenzhen Ant Hi-Tech Industrial Co., Ltd.2011-07-01
SEDAT FLAMINGO (K082755)Sedat2008-12-15
QL LOCKING SYRINGE (K060643)Atrion Medical Products, Inc.2006-07-12
DOLPHIN INFLATION DEVICE (K042449)Sedat S.A.2005-04-18
VICEROY INFLATION DEVICE (K040138)Merit Medical Systems, Inc.2004-02-13
VANGUARD REPROCESSED INFLATION DEVICES (K012480)Vanguard Medical Concepts, Inc.2002-01-22
INTELLISYSTEM II COLOR MONITOR (K993341)Merit Medical Systems, Inc.1999-10-25
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) (K962495)Advanced Cardiovascular Systems, Inc.1996-09-12
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT (K960983)Medtronics Interventional Vascular1996-05-30
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) (K961471)Advanced Cardiovascular Systems, Inc.1996-05-08
USCI IDEAL PTCA KIT (K953522)Ryder Intl. Corp.1996-04-17
BREEZE DIGITAL INFLATION DEVICE (K953676)Namic1996-03-29
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE (K955869)Scimed Life Systems, Inc.1996-03-22
OSCILFLATOR (K952566)Surgical Technologies, Inc.1995-08-31
MONARCH AP(TM) (K943597)Merit Medical Systems, Inc.1995-02-10
MEDTRONIC EVEREST INFLATION DEVICE (K942269)Medtronics Interventional Vascular1994-10-18
MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE (K940896)Medex, Inc.1994-08-11
IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING (K940425)Imagyn Medical, Inc.1994-08-01
ANGEION IGITAL ANGEFLATOR (K921757)Angeion Corp.1993-03-18
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE (K922573)Boston Scientific Corp1992-12-08
ACS ANGIOTRAK(TM) SYSTEM (K921719)Advanced Cardiovascular Systems, Inc.1992-08-07
MONARCH(TM) INFLATION SYRINGE (K913994)Merit Medical Systems, Inc.1992-02-04
CORDIS INFLATOR DEVICE (K912644)Cordis Corp.1991-09-16
ANGIOPLASTY INFLATOR (K911295)Vastek1991-07-12
MEDFLATOR INFLATION SYSTEM (K910958)Medex, Inc.1991-07-12
BIPOLAR FORCEPS (K912544)Everest Medical Corp.1991-06-24
CONDOR ANALOG INFLATION SYRINGE (K904508)Professional Medical Services1991-04-02
LP-60 LOW PRESSURE INFLATION DEVICE (K910205)Devices For Vascular Intervention, Inc.1991-02-25
CONDOR DIGITAL INFLATION SYRINGE (K904954)Professional Medical Services1991-01-16
MORSE BALLOON INFLATION DEVICE (K904275)North American Instrument Corp.1991-01-03
MAGNUM-20 (TM) INFLATION DEVICE (K903621)Vascumed Systems1990-12-20
DISPOSABLE INFLATION GAUGE (K902695)Cook Urological, Inc.1990-12-03
INFLATION/DEFLATION DEVICE (K904394)Boston Scientific Corp1990-12-03
SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 (K903503)Scimed1990-10-09
CATHETER BALLOON DILATOR PRESSURE GAUGE (K895511)Argon Medical Corp.1990-02-28
ACS INDEFLATOR XX (K896849)Advanced Cardiovascular Systems, Inc.1990-02-28
SMALL CATHETER INFLATOR (K896005)Allied Systems Co.1990-02-26
INFLATION PRO II (K895836)Baxter Healthcare Corp1989-12-20
SCHNEIDER-SHILEY INFLATION SYRINGES (K861607)Shiley, Inc.1986-06-09
MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) (K853136)E.A. Fischione Instrument Mfg.1985-12-03
SCIMED PM200 INFLATION MANOMETER (K843448)Scimed Life Systems, Inc.1984-10-23
EDSLAB PRESSURE GAUGE (K832323)American Edwards Laboratories1983-08-11
DORROS-SPRING PRESSURIZER (K812304)Cardiovascular Diagnostic Services1981-10-13

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