Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MAV — Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
235 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Ever | Medtronic Vascular | 2022-04-13 | 28 | 0 |
| K162272 | Fluent inflation device | Vascular Solutions, Inc. | 2016-10-20 | 69 | 0 |
| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival | Medtronic, Inc. | 2016-04-13 | 177 | 0 |
| K153672 | basixTOUCH40 Inflation Syringe | Merit Medical Systems, Inc. | 2016-01-20 | 30 | 0 |
| K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | 2015-12-18 | 116 | 0 |
| K140943 | MASTRO PLUS BALLOON IN-DEFLATION DEVICE | Beijing Demax Medical Technology Co.,Ltd | 2015-03-05 | 325 | 0 |
| K143522 | Presto Inflation Device | C.R. Bard, Inc. | 2015-01-12 | 31 | 0 |
| K133795 | SUMMED INFLATION DEVICE KIT | Sunny Medical Device (Shenzhen) Co., Ltd. | 2014-12-12 | 364 | 0 |
| K140745 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | 2014-04-17 | 23 | 1 |
| K130566 | BASIXTOUCH | Merit Medical Systems, Inc. | 2013-06-19 | 107 | 0 |
| K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE | Merit Medical Ireland, Ltd. | 2012-12-19 | 140 | 0 |
| K122152 | OXTI INFLATION DEVICE | Oxti Corporation | 2012-12-14 | 147 | 0 |
| K123214 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | 2012-11-13 | 29 | 0 |
| K120694 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | 2012-04-03 | 27 | 0 |
| K102648 | ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2011-07-01 | 290 | 0 |
| K082755 | SEDAT FLAMINGO | Sedat | 2008-12-15 | 87 | 1 |
| K060643 | QL LOCKING SYRINGE | Atrion Medical Products, Inc. | 2006-07-12 | 124 | 0 |
| K042449 | DOLPHIN INFLATION DEVICE | Sedat S.A. | 2005-04-18 | 221 | 1 |
| K040138 | VICEROY INFLATION DEVICE | Merit Medical Systems, Inc. | 2004-02-13 | 22 | 2 |
| K012480 | VANGUARD REPROCESSED INFLATION DEVICES | Vanguard Medical Concepts, Inc. | 2002-01-22 | 173 | 0 |
| K993341 | INTELLISYSTEM II COLOR MONITOR | Merit Medical Systems, Inc. | 1999-10-25 | 20 | 4 |
| K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 | Advanced Cardiovascular Systems, Inc. | 1996-09-12 | 78 | 0 |
| K960983 | MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT | Medtronics Interventional Vascular | 1996-05-30 | 80 | 3 |
| K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (W | Advanced Cardiovascular Systems, Inc. | 1996-05-08 | 21 | 4 |
| K953522 | USCI IDEAL PTCA KIT | Ryder Intl. Corp. | 1996-04-17 | 265 | 0 |
| K953676 | BREEZE DIGITAL INFLATION DEVICE | Namic | 1996-03-29 | 235 | 0 |
| K955869 | SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE | Scimed Life Systems, Inc. | 1996-03-22 | 87 | 0 |
| K952566 | OSCILFLATOR | Surgical Technologies, Inc. | 1995-08-31 | 90 | 0 |
| K943597 | MONARCH AP(TM) | Merit Medical Systems, Inc. | 1995-02-10 | 202 | 0 |
| K942269 | MEDTRONIC EVEREST INFLATION DEVICE | Medtronics Interventional Vascular | 1994-10-18 | 161 | 5 |
| K940896 | MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE | Medex, Inc. | 1994-08-11 | 168 | 0 |
| K940425 | IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE T | Imagyn Medical, Inc. | 1994-08-01 | 182 | 0 |
| K921757 | ANGEION IGITAL ANGEFLATOR | Angeion Corp. | 1993-03-18 | 339 | 0 |
| K922573 | 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE | Boston Scientific Corp | 1992-12-08 | 190 | 0 |
| K921719 | ACS ANGIOTRAK(TM) SYSTEM | Advanced Cardiovascular Systems, Inc. | 1992-08-07 | 120 | 0 |
| K913994 | MONARCH(TM) INFLATION SYRINGE | Merit Medical Systems, Inc. | 1992-02-04 | 151 | 0 |
| K912644 | CORDIS INFLATOR DEVICE | Cordis Corp. | 1991-09-16 | 91 | 0 |
| K911295 | ANGIOPLASTY INFLATOR | Vastek | 1991-07-12 | 109 | 0 |
| K910958 | MEDFLATOR INFLATION SYSTEM | Medex, Inc. | 1991-07-12 | 128 | 0 |
| K912544 | BIPOLAR FORCEPS | Everest Medical Corp. | 1991-06-24 | 14 | 0 |
| K904508 | CONDOR ANALOG INFLATION SYRINGE | Professional Medical Services | 1991-04-02 | 180 | 0 |
| K910205 | LP-60 LOW PRESSURE INFLATION DEVICE | Devices For Vascular Intervention, Inc. | 1991-02-25 | 40 | 0 |
| K904954 | CONDOR DIGITAL INFLATION SYRINGE | Professional Medical Services | 1991-01-16 | 72 | 0 |
| K904275 | MORSE BALLOON INFLATION DEVICE | North American Instrument Corp. | 1991-01-03 | 107 | 0 |
| K903621 | MAGNUM-20 (TM) INFLATION DEVICE | Vascumed Systems | 1990-12-20 | 134 | 0 |
| K902695 | DISPOSABLE INFLATION GAUGE | Cook Urological, Inc. | 1990-12-03 | 167 | 0 |
| K904394 | INFLATION/DEFLATION DEVICE | Boston Scientific Corp | 1990-12-03 | 69 | 0 |
| K903503 | SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 | Scimed | 1990-10-09 | 67 | 0 |
| K895511 | CATHETER BALLOON DILATOR PRESSURE GAUGE | Argon Medical Corp. | 1990-02-28 | 169 | 0 |
| K896849 | ACS INDEFLATOR XX | Advanced Cardiovascular Systems, Inc. | 1990-02-28 | 85 | 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