Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Devicor Medical Products, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
283 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260365 | Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy Syste | Devicor Medical Products, Inc. | 2026-03-04 | 28 | 0 |
| K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); | Devicor Medical Products, Inc. | 2026-01-23 | 59 | 0 |
| K243095 | Mammotome AutoCore™ Single Insertion Core Biopsy System | Devicor Medical Products, Inc. | 2024-10-29 | 29 | 0 |
| K240527 | HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape | Devicor Medical Products, Inc. | 2024-07-10 | 138 | 0 |
| K232615 | LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMA | Devicor Medical Products, Inc. | 2024-01-12 | 137 | 0 |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2023-07-13 | 373 | 0 |
| K212158 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2022-04-21 | 283 | 1 |
| K210752 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2021-04-14 | 30 | 0 |
| K203097 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2020-12-16 | 63 | 0 |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | Devicor Medical Products, Inc. | 2020-08-18 | 28 | 0 |
| K170803 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2017-06-15 | 90 | 0 |
| K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Bio | Devicor Medical Products, Inc. | 2016-08-08 | 229 | 0 |
| K161021 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2016-05-05 | 23 | 0 |
| K152989 | Mammotome revolve Dual Vacuum Assist Biopsy System | Devicor Medical Products, Inc. | 2016-02-25 | 135 | 1 |
| K123259 | MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM | Devicor Medical Products, Inc. | 2012-11-15 | 28 | 1 |
| K112411 | MAMMOTOME ELITE BIOPSY SYSTEM | Devicor Medical Products, Inc. | 2012-03-20 | 211 | 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