510(k) Report

510(k) · Cleared

Recalled · 2006

Rubicor Breast Biopsy Device

K020047510(k) TraditionalCleared Apr 5, 200288-day reviewClass II21 CFR 878.4400Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rubicor Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 5, 2002 as substantially equivalent to K003190 (Neothermia Corp., 2001) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it. It has been recalled once.

Decided
Apr 5, 2002
Review
88 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K922123 (1993). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor2002: 1 descendant cleared2003: 2 descendants cleared2005: 1 descendant cleared2007: 1 descendant clearedK922123 · Auto Suture Disposable Endoscopic Specimen Pouch · United States Surgical, A Division of Tyco Healthc · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 1 descendant K922123 · Auto Suture Disposable Endoscopic Specimen Pouch · United States Surgical, A Division of Tyco Healthc · 19930
  1. Root · 1 generation backK922123 Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc · 1993
  2. This deviceK020047 Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 2002
  3. Descendant · cites it directly · 4 of its ownK023601 Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK030049 Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2003 · Recalled
  5. Descendant · 2 generations on · 1 of its ownK052506 Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 2005 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK070275 Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc. · 2007
  7. Descendant · 2 generations on · 0 of its ownK032584 Rubicor Encapsule Breast Biopsy Device, Model 30629Rubicor Medical, Inc. · 2003 · Recalled

Most influential descendants

Showing 5 of 5 · See all
  • K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2002 · cites it directly4descendants
  • K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2003 · 2 generations on3descendants
  • K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 2005 · 2 generations on1descendant
  • K070275Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc. · 2007 · 3 generations on0descendants
  • K032584Rubicor Encapsule Breast Biopsy Device, Model 30629Rubicor Medical, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922123Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc1993—
0 (this device)K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc.2002—
+1K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20021
+2K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20031
+2K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc.20051
+3K070275Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc.2007—
+2K032584Rubicor Encapsule Breast Biopsy Device, Model 30629Rubicor Medical, Inc.20031

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200510
200710
FIG. 1 — Lineage of K020047, 1993–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003190EN Bloc Biopsy System
Summary page 1
…(21 CFR 870.4400) Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the Neothermia En Bloc Biopsy System (K003190), the Ethicon Mammotome Hand-Held System (K991980) and the USSC Autosuture Endo Catch (K922123). Intended Use: : : The Rubicor B…
Neothermia Corp.200111
*K991980Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and…
Summary page 1
…device is substantially equivalent in intended use and/or method of operation to the Neothermia En Bloc Biopsy System (K003190), the Ethicon Mammotome Hand-Held System (K991980) and the USSC Autosuture Endo Catch (K922123). Intended Use: : : The Rubicor Breast Biopsy Device is intended for diagnostic sam…
Ethicon Endo-Surgery, Inc.1999—
*K922123Auto Suture Disposable Endoscopic Specimen Pouch
Summary page 1
…ed use and/or method of operation to the Neothermia En Bloc Biopsy System (K003190), the Ethicon Mammotome Hand-Held System (K991980) and the USSC Autosuture Endo Catch (K922123). Intended Use: : : The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy…
United States Surgical, A Division of Tyco Healthc1993—

Also cleared against K003190: 3 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20024

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 17, 2006Not classifiedZ-0715-06OtherDevices' sterility may be compromised due to lack of adequate sterilization.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K023601 (Rubicor Medical, Inc., 2002) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K003190.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure.

The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K003190

3 other devices cite the same predicate.

  • K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation · 2005
  • K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002
  • K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302Neothermia Corp. · 2002

More from Rubicor Medical, Inc.

8 FDA decisions under this applicant name. See the company

  • 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

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The GEI category page

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https://510kreport.com/device/K020047 · printed Nov 3, 2026

Cite this page

510(k) Report. “K020047: Rubicor Breast Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020047

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026