Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DRE — Predicate Candidate Screening
105 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
195 days90th percentile
105clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | 2026-07-27 | 97 | 0 |
| K253616 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | 2025-12-19 | 31 | 0 |
| K251325 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2025-05-29 | 30 | 0 |
| K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | 2025-01-15 | 169 | 0 |
| K241720 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2024-07-12 | 28 | 0 |
| K233647 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2023-12-14 | 30 | 0 |
| K232609 | Micro Ace™ Advanced Micro Access System | Merit Medical Systems, Inc. | 2023-09-27 | 30 | 0 |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-0 | Spectranetics, Inc. | 2022-12-15 | 28 | 0 |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | 2022-08-24 | 357 | 0 |
| K211679 | Xtractor device | Xcardia Innovation , Ltd. | 2022-02-17 | 261 | 0 |
| K210734 | Endovascular Dilator and Sets | Cook Incorporated | 2021-04-06 | 26 | 0 |
| K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020-06-12 | 29 | 0 |
| K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vesse | Medron, LLC | 2020-05-06 | 258 | 0 |
| K200379 | Super Sheath | Togo Medikit Co., Ltd. | 2020-03-19 | 30 | 0 |
| K192195 | Sterile Dilator | Galt Medical Corp. | 2019-09-26 | 44 | 0 |
| K190175 | S-MAK XL | Merit Medical Systems, Inc. | 2019-04-10 | 68 | 0 |
| K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019-03-21 | 232 | 0 |
| K183036 | Dilator Sets | Cook Incorporated | 2018-12-20 | 49 | 3 |
| K182914 | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | 2018-10-29 | 11 | 0 |
| K172487 | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | 2017-10-16 | 60 | 0 |
| K162389 | Medcomp Vessel Dilator | Medcomp ( Medical Components) | 2017-06-01 | 279 | 0 |
| K170616 | van Andel Dilatation Catheter | Cook Incorporated | 2017-04-28 | 58 | 0 |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Se | Cardiacassist, Inc. | 2017-01-06 | 155 | 0 |
| K161336 | VSI StraitSet micro-introducer kit | Vascular Solutions, Inc. | 2016-08-11 | 90 | 0 |
| K150932 | Sheath Introducer | Bioteque Corp. | 2016-07-22 | 473 | 0 |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | 2016-07-08 | 57 | 0 |
| K151877 | MicroTract Access System | Arstasis, Inc. | 2015-08-07 | 29 | 0 |
| K151076 | MicroTaper Needle Introducer Set | Summit Access, LLC | 2015-05-22 | 30 | 0 |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating D | Spectranetics, Inc. | 2015-03-04 | 20 | 0 |
| K141070 | SUPER SHEATH | Togo Medikit Co., Ltd. | 2015-01-15 | 265 | 0 |
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie M | Cook Vascular, Inc. | 2014-11-12 | 86 | 0 |
| K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator She | Spectranetics, Inc. | 2014-09-25 | 15 | 0 |
| K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTI | Cook Vascular, Inc. | 2014-07-01 | 57 | 0 |
| K141131 | TIGHTRAIL MINI | Spectranetics, Inc. | 2014-05-23 | 22 | 0 |
| K140047 | LEXICONTURE MECHANICAL DILATOR SHEATH SET | Spectranetics Corp. | 2014-04-09 | 90 | 0 |
| K133631 | LEXIPLIANT DILATOR SHEATH SET | Spectranetics Corporation | 2014-03-27 | 121 | 0 |
| K132713 | NMI COAXIAL MICROINTRODUCER SET | Navilyst Medical, Inc. | 2013-09-27 | 28 | 15 |
| K123842 | LAWMAX DILATOR | Lifetech Scientific (Shenzhen) Co., Ltd. | 2013-06-24 | 193 | 0 |
| K130791 | PRELUDE SHEATH INTRODUCER | Merit Medical Systems, Inc. | 2013-06-07 | 77 | 0 |
| K123445 | NMI COAXIAL MICROINTRODUCER SET | Navilyst Medical, Inc. | 2013-04-01 | 144 | 0 |
| K120349 | SONIXGPS VASCULAR ACCESS NEEDLE KIT | Ultrasonix Medical Corpation | 2012-04-09 | 63 | 0 |
| K103421 | ARSTASIS DILATOR ADAPTER | Arstasis, Inc. | 2011-05-24 | 183 | 0 |
| K093554 | RETROFLEX DILATOR KIT | Edwards Lifesciences, LLC | 2010-04-13 | 147 | 0 |
| K092378 | SPECTRANETICS VISISHEATH DILATOR SHEATH | Spectranetics Corp. | 2009-11-02 | 89 | 0 |
| K091584 | MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE | Merit Medical Systems, Inc. | 2009-10-09 | 129 | 0 |
| K081940 | AVALON ELITE VASCULAR ACCESS KIT | Avalon Laboratories, LLC | 2008-11-18 | 133 | 0 |
| K082075 | HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER | Hansen Medical, Inc. | 2008-08-15 | 23 | 0 |
| K073035 | PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS | Merit Medical Systems, Inc. | 2007-11-20 | 22 | 0 |
| K071330 | GALTSTICK INTRODUCER SYSTEM | Galt Medical Corp. | 2007-10-31 | 173 | 0 |
| K070749 | ESTECH PERCUTANEOUS INSERTION DILATOR KIT | Coombs Medical Device Consulting | 2007-10-24 | 219 | 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