Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NEU — Predicate Candidate Screening
110 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
272 days90th percentile
110clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); | Devicor Medical Products, Inc. | 2026-01-23 | 59 | 0 |
| K253888 | MOLLI 2 System | Stryker Endoscopy | 2025-12-31 | 27 | 1 |
| K252892 | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | 2025-12-19 | 99 | 0 |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | 2025-12-12 | 168 | 0 |
| K251748 | MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. | 2025-07-23 | 47 | 0 |
| K243642 | UltraCor™ Twirl™ Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2025-03-24 | 118 | 0 |
| K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | 2024-12-20 | 403 | 0 |
| K240429 | Trilogy Tissue Marker | Inrad, Inc. | 2024-11-07 | 268 | 0 |
| K234149 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-26 | 272 | 0 |
| K240042 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-25 | 264 | 0 |
| K241762 | OneMark | View Point Medical | 2024-09-16 | 88 | 0 |
| K240527 | HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape | Devicor Medical Products, Inc. | 2024-07-10 | 138 | 0 |
| K232865 | Magseed Pro Magnetic Marker System | Endomagnetics Ltd., | 2024-06-28 | 287 | 2 |
| K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | 2024-02-12 | 266 | 0 |
| K230836 | SchurSign Tissue Marker | Surgmark GmbH | 2024-01-23 | 302 | 0 |
| K232615 | LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMA | Devicor Medical Products, Inc. | 2024-01-12 | 137 | 0 |
| K231579 | MOLLI 2 | Molli Surgical, Inc. | 2023-10-26 | 148 | 1 |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2023-07-13 | 373 | 0 |
| K222832 | Sentimag System | Endomagnetics Ltd., | 2023-01-21 | 123 | 0 |
| K223107 | MOLLI 2 | Molli Surgical, Inc. | 2023-01-18 | 110 | 0 |
| K212158 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2022-04-21 | 283 | 1 |
| K212882 | SCOUT BX Delivery System | Merit Medical Systems, Inc. | 2022-04-08 | 210 | 0 |
| K210600 | MOLLI | Molli Surgical, Inc. | 2021-04-16 | 46 | 0 |
| K210752 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2021-04-14 | 30 | 0 |
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Profess | Somatex Medical Technologies GmbH | 2021-02-18 | 227 | 0 |
| K203097 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2020-12-16 | 63 | 0 |
| K192771 | C4 Fiducial Marker | C4 Imaging, LLC | 2020-10-21 | 387 | 0 |
| K193189 | RFID Localization System | Health Beacons, Inc. | 2020-05-06 | 169 | 0 |
| K183503 | EasyMark Tissue Marker | Inrad, Inc. | 2019-10-17 | 304 | 0 |
| K192371 | BioZorb SP Marker | Focal Therapeutics | 2019-09-26 | 27 | 0 |
| K190932 | RFID Localization System | Health Beacons, Inc. | 2019-09-13 | 156 | 0 |
| K190689 | SignalMark Breast Marker | View Point Medical, Inc. | 2019-08-14 | 149 | 0 |
| K183400 | EnVisio Navigation Sytem | Elucent Medical, Inc. | 2019-03-22 | 105 | 1 |
| K182082 | Tumark for Eviva, Tumark for Brevera | Somatex Medical Technologies GmbH | 2018-10-31 | 90 | 0 |
| K181692 | 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator | Health Beacons, Inc. | 2018-09-25 | 90 | 0 |
| K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2018-08-02 | 107 | 0 |
| K180621 | EchoMark, EchoMark LP | Sonavex, Inc. | 2018-06-06 | 89 | 0 |
| K180640 | SmartClip Soft Tissue Marker | Elucent Medical, Inc. | 2018-06-04 | 84 | 0 |
| K180443 | Tumark Vision | Somatex Medical Technologies GmbH | 2018-03-22 | 30 | 0 |
| K180061 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2018-03-09 | 60 | 0 |
| K173587 | Magseed Magnetic Marker Systtem | Endomagnetics Ltd., | 2018-02-16 | 88 | 0 |
| K171767 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2017-10-31 | 139 | 0 |
| K170803 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2017-06-15 | 90 | 0 |
| K170026 | Radiopaque Tissue Marker | Viscus Biologics, LLC | 2017-06-02 | 150 | 0 |
| K170905 | Star Tissue Marker | Scion Medical Technologies, LLC | 2017-04-27 | 30 | 0 |
| K152510 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2016-05-13 | 254 | 0 |
| K161021 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2016-05-05 | 23 | 0 |
| K152586 | Beacon Fine Needle Fiducial System | Covidien, LLC | 2015-12-30 | 111 | 0 |
| K153189 | Beacon Tissue Marker (SE) | Scion Medical Technologies, LLC | 2015-12-17 | 44 | 0 |
| K152070 | BioZorb LP Marker | Focal Therapeutics | 2015-08-26 | 30 | 3 |
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