510(k) Report

510(k) · Cleared

Recalled · 2006

Rubicor Encapsule Breast Biopsy Device, Model 30629

K032584510(k) SpecialCleared Sep 17, 200327-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 Sep 17, 2003 as substantially equivalent to K023601 (Rubicor Medical, Inc., 2002) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1993. It has been recalled once.

Decided
Sep 17, 2003
Review
27 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
2

Its longest line of descent runs back 4 generations to K922123 (1993). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1999: 1 other ancestorK922123 · Auto Suture Disposable Endoscopic Specimen Pouch · United States Surgical, A Division of Tyco Healthc · 1993K020047 · Rubicor Breast Biopsy Device · Rubicor Medical, Inc. · 2002 · recalledK023601 · Rubicor Encapsule Breast Biopsy Device, Model 30086 · Rubicor Medical, Inc. · 2002 · recalledK030049 · Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086 · Rubicor Medical, Inc. · 2003 · recalled1990199520002005
Other ancestors, by generation 3 generations back: 2 other ancestors K030049 · Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086 · Rubicor Medical, Inc. · 2003 · recalledK023601 · Rubicor Encapsule Breast Biopsy Device, Model 30086 · Rubicor Medical, Inc. · 2002 · recalledK020047 · Rubicor Breast Biopsy Device · Rubicor Medical, Inc. · 2002 · recalledK922123 · Auto Suture Disposable Endoscopic Specimen Pouch · United States Surgical, A Division of Tyco Healthc · 19930
  1. Root · 4 generations backK922123 Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 3 generations backK020047 Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 2002 · Recalled
  3. 2 generations backK023601 Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2002 · Recalled
  4. 1 generation backK030049 Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2003 · Recalled
  5. This deviceK032584 Rubicor Encapsule Breast Biopsy Device, Model 30629Rubicor Medical, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922123Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc1993—
−3K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc.20021
−2K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20021
−1K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20031
0 (this device)K032584Rubicor Encapsule Breast Biopsy Device, Model 30629Rubicor Medical, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
FIG. 1 — Lineage of K032584, 1993–2003Source: 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? (2)

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
*K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20021
*K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086
Summary page 1
…evice: The subject device and accessory are substantially equivalent in intended use and/or method of operation to the Rubicor EncapsuleTMBreast Biopsy Device (KO23601 & K030049) Intended Use: The EncapsuleTMBreast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy pro…
Rubicor Medical, Inc.20031

Also cleared against K023601: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8 months on median.
  • 4 of the 6 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K023601.

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 Encapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. The Encapsule Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged…

Read the full statement (133 words)

The Encapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Encapsule Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K023601

2 other devices cite the same predicate.

  • K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 20051 recall
  • K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 20031 recall

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
  • K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 20031 recall

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The GEI category page

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https://510kreport.com/device/K032584 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032584: Rubicor Encapsule Breast Biopsy Device, Model 30629.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032584

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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