510(k) Report

FDA applicant

Rubicor Medical, Inc.

San Carlos, CA8 decisions2002–20071 recall

FDA records 8 decisions for Rubicor Medical, Inc. (San Carlos, CA) from 2002 to 2007: 8 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KNW (Instrument, Biopsy). Its devices cite 17 predicates, 8 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Rubicor Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rubicor Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rubicor Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories6decisions
  • KNWInstrument, Biopsy2decisions

Whose devices does it build on?

Its devices cite 17 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 20023cite it
  • K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 20032cite it
  • K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 20052cite it
  • K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 20021cites it
  • K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 20051cites it
  • K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 20071cites it

What has FDA decided for it lately?

  • K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007
  • K070275Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc. · 2007
  • K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005
  • K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 20051 recall
  • K032584Rubicor Encapsule Breast Biopsy Device, Model 30629Rubicor Medical, Inc. · 20031 recall
  • K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 20031 recall
  • K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 20021 recall
  • K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 20021 recall

All 8 as Rubicor Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K020047Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and…Feb 17, 2006