# Devicor Medical Products, Inc.

- Location (FDA's records): Cincinnati, OH
- FDA decisions: 16 (2012–2026): 16 510(k) clearances
- Product codes: NEU (9), KNW (7)
- 510(k) review time since 2016: median 90 days, against 127 for FDA's reviews in the same codes and years (8 of 11 faster)
- Predicates its devices cite: 19 (10 its own); citations of its devices by later devices: 12 (10 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ethicon Endo-Surgery, Inc.: 4 (https://510kreport.com/company/ethicon-endo-surgery)
- Biopsy Sciences, LLC: 3 (https://510kreport.com/company/biopsy-sciences)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)

## Firms that cite its devices most
- Transmed7, LLC: 1 (https://510kreport.com/company/transmed7)
- Neodynamics AB: 1 (https://510kreport.com/company/neodynamics)

## Its most-cited devices
- K153709: Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet,  Mammotome elite Biopsy System-10G Introducer Stylet (2016), cited by 2
- K212158: HydroMARK Breast Biopsy Site Marker (2022), cited by 2
- K161021: HydroMARK Breast Biopsy Site Marker (2016), cited by 2
- K221961: HydroMARK Plus Breast Biopsy Site Marker (2023), cited by 2
- K112411: Mammotome Elite Biopsy System (2012), cited by 1
- K152989: Mammotome revolve Dual Vacuum Assist Biopsy System (2016), cited by 1

## Recent decisions
- 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 (Mar 4, 2026)
- K253761: HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (Jan 23, 2026)
- K243095: Mammotome AutoCore™ Single Insertion Core Biopsy System (Oct 29, 2024)
- K240527: HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) (Jul 10, 2024)
- K232615: LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) (Jan 12, 2024)
- K221961: HydroMARK Plus Breast Biopsy Site Marker (Jul 13, 2023)
- K212158: HydroMARK Breast Biopsy Site Marker (Apr 21, 2022)
- K210752: HydroMARK Breast Biopsy Site Marker (Apr 14, 2021)

Source page: https://510kreport.com/company/devicor-medical-products