Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DXC — Predicate Candidate Screening
205 FDA 510(k) clearances under this product code; the 50 most recent screened below.
94 daysmedian FDA review time
272 days90th percentile
205clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262086 | PreludeSYNC™ Radial Compression Device | Merit Medical Systems, Inc. | 2026-07-22 | 30 | 0 |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences | 2026-06-05 | 143 | 0 |
| K252772 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | 2026-05-22 | 262 | 0 |
| K254060 | Life Saving Tourniquet | TW Medical | 2026-04-03 | 107 | 0 |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); | Arc Trauma, LLC | 2025-12-31 | 401 | 0 |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm | Medline Industries, LP | 2025-11-20 | 58 | 0 |
| K232577 | Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd | 2024-01-18 | 146 | 0 |
| K230281 | PICOCLAMP | Kono Seisakusho Co., Ltd. | 2023-10-23 | 264 | 0 |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJ | Compression Works, Inc. | 2023-03-03 | 268 | 0 |
| K230248 | VIOLA | Vascular Graft Solutions, Ltd. | 2023-02-28 | 29 | 0 |
| K222182 | Radial Artery Compression Tourniquets | Beijing Demax Medical Technology Co.,Ltd | 2023-01-04 | 166 | 0 |
| K221843 | GEM Biover Microvascular Clamps | Synovis Micro Companies Alliance, Inc. | 2022-09-14 | 82 | 0 |
| K213531 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2021-12-20 | 45 | 0 |
| K210681 | SiteSeal SV | Ensite Vascular | 2021-04-06 | 29 | 0 |
| K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021-03-04 | 59 | 0 |
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061 | Carefusion 2200, Inc. | 2021-03-04 | 28 | 0 |
| K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021-02-17 | 100 | 0 |
| K203803 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | 2021-01-26 | 29 | 0 |
| K201695 | Patent Hemostasis Band (PH Band) | Medical Ingenuities | 2020-10-30 | 130 | 0 |
| K192413 | SiteSeal Femoral Compression Device | Ensite Vacular, LLC | 2020-03-31 | 209 | 0 |
| K191827 | Sunmed Disposable Angio-Closure Pads | Sunny Medical Device (Shenzhen) Co., Ltd. | 2020-03-16 | 252 | 0 |
| K190351 | Site Seal SV | Ensite Vascular | 2019-07-02 | 138 | 0 |
| K190318 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | 2019-03-14 | 29 | 0 |
| K180723 | PreludeSYNC DISTAL Radial Compression System | Merit Medical Systems, Inc. | 2018-04-17 | 29 | 0 |
| K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | Tz Medical, Inc. | 2018-01-10 | 54 | 0 |
| K170958 | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPuls | Tricol Biomedical, Inc. | 2017-08-29 | 151 | 0 |
| K163693 | IntraClude Intra-Aortic Occlusion Device | Edwards Lifesciences, LLC | 2017-01-26 | 29 | 1 |
| K162988 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | 2017-01-25 | 90 | 1 |
| K162027 | TRAcelet Compression Device | Medtronic Vascular | 2016-10-21 | 91 | 0 |
| K161315 | Vein Clamps, Artery Clamps | Aros Surgical Instruments Corporation | 2016-08-18 | 99 | 0 |
| K153259 | VasoStat Hemostasis Device | Forge Medical, Inc. | 2016-01-06 | 57 | 0 |
| K152525 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2015-11-10 | 68 | 0 |
| K151363 | Zephyr Vascular Compression Device | Advanced Vascular Dynamics | 2015-07-31 | 71 | 0 |
| K143078 | Bookwalter Gordon Adjustable Compression Element | Symmetry Surgical | 2015-05-14 | 199 | 0 |
| K150813 | iTClamp50 | Innovative Trauma Care, Inc. | 2015-04-30 | 34 | 0 |
| K141685 | CROC | Combat Medical Systems, LLC | 2015-01-26 | 217 | 0 |
| K142122 | RADAR VASCULAR COMPRESSION DEVICE | Advanced Vascular Dynamics | 2014-12-04 | 122 | 0 |
| K142359 | Vasc Band hemostat | Lepu Medical Technology (Beijing) Co., Ltd. | 2014-10-23 | 59 | 0 |
| K140805 | ITCLAMP 50 | Innovative Trauma Care, Inc. | 2014-10-09 | 191 | 0 |
| K132293 | SYVEK RADIAL BAND | Marine Polymer Technologies | 2014-07-31 | 373 | 0 |
| K133029 | ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE | Compression Works, LLC | 2013-12-06 | 71 | 0 |
| K132651 | ITCLAMP 50 | Innovative Trauma Care, Inc. | 2013-10-28 | 63 | 0 |
| K131411 | COSEAL | Jilin Coronado Medical , Ltd. | 2013-09-26 | 134 | 0 |
| K132175 | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER | Edwards Lifesciences, LLC | 2013-09-13 | 60 | 2 |
| K123571 | CARDIO VISION MICS AORTIC CLAMPS | Cardiomedical GmbH | 2013-08-01 | 254 | 0 |
| K131561 | SAM JUNCTIONAL TOURNIQUET | Sam Medical Products | 2013-07-24 | 55 | 1 |
| K130382 | HEARTSTRING III PROXIMAL SEAL SYSTEM | Boston Scientific Corporation | 2013-06-05 | 111 | 3 |
| K123041 | VASOSTAT HEMOSTASIS DEVICE | Forge Medical, Inc. | 2013-05-29 | 243 | 0 |
| K123077 | VASCULAR CLAMPS | Hebumedical GmbH | 2013-05-14 | 225 | 0 |
| K123551 | ITCLAMP 50 | Innovative Trauma Care, Inc. | 2013-05-14 | 176 | 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