Devicor Medical Products, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Devicor Medical Products, Inc.” (first 2012, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. Since 2017 the median was 63 days, against 123 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 120 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 135 |
| 2017 | 1 | 90 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 46 |
| 2021 | 1 | 30 |
| 2022 | 1 | 283 |
| 2023 | 1 | 373 |
| 2024 | 3 | 137 |
| 2025 | 0 | — |
| 2026 | 2 | 44 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Devicor Medical Products, Inc. took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | 9 | 9 |
| KNW | Instrument, Biopsy | 7 | 7 |
Review panels
Most recent Devicor Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | KNW | 2026-03-04 | 28 |
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | NEU | 2026-01-23 | 59 |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy System | KNW | 2024-10-29 | 29 |
| K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | NEU | 2024-07-10 | 138 |
| K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape)) | NEU | 2024-01-12 | 137 |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | NEU | 2023-07-13 | 373 |
| K212158 | HydroMARK Breast Biopsy Site Marker | NEU | 2022-04-21 | 283 |
| K210752 | HydroMARK Breast Biopsy Site Marker | NEU | 2021-04-14 | 30 |
| K203097 | HydroMARK Breast Biopsy Site Markers | NEU | 2020-12-16 | 63 |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | KNW | 2020-08-18 | 28 |
6 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 5 recall events; 2 initiated in the last five years. Most recent: 2026-04-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Devicor Medical Products, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04622696: HydroMARK Post-market Clinical Follow-up Study (Completed, started 2021-02-16)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Devicor Medical Products, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Devicor Medical Products, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Devicor Medical Products, Inc.” (first 2012, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Devicor Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Devicor Medical Products, Inc. is 76 days. Since 2017: 63 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Devicor Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are NEU (Marker, Radiographic, Implantable, 9); KNW (Instrument, Biopsy, 7).
Next steps
- See all 16 Devicor Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NEU, Devicor Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.