510(k) · Cleared
Recalled · 2006Rubicor Encapsule Breast Biopsy Device, Model 30086
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rubicor Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 19, 2002 as substantially equivalent to K020047 (Rubicor Medical, Inc., 2002) after a 22-day review. Its family tree reaches back 2 generations to 1993. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 19, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922123 (1993). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK922123 Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc · 1993
- 1 generation backK020047 Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 2002 · Recalled
- This deviceK023601 Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK030049 Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2003 · Recalled
- Descendant · cites it directly · 1 of its ownK052506 Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK070275 Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK032584 Rubicor Encapsule Breast Biopsy Device, Model 30629Rubicor Medical, Inc. · 2003 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2003 · cites it directly3descendants
- K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 2005 · cites it directly1descendant
- K070275Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc. · 2007 · 2 generations on0descendants
- K032584Rubicor Encapsule Breast Biopsy Device, Model 30629Rubicor Medical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922123 | Auto Suture Disposable Endoscopic Specimen Pouch | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −1 | K020047 | Rubicor Breast Biopsy Device | Rubicor Medical, Inc. | 2002 | 1 |
| 0 (this device) | K023601 | Rubicor Encapsule Breast Biopsy Device, Model 30086 | Rubicor Medical, Inc. | 2002 | — |
| +1 | K030049 | Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086 | Rubicor Medical, Inc. | 2003 | 1 |
| +1 | K052506 | Rubicor Encapsule Breast Biopsy Device, Model 31108 | Rubicor Medical, Inc. | 2005 | 1 |
| +2 | K070275 | Flexible Loop Electrosurgical Electrode | Rubicor Medical, Inc. | 2007 | — |
| +1 | K032584 | Rubicor Encapsule Breast Biopsy Device, Model 30629 | Rubicor Medical, Inc. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020047 | Rubicor Breast Biopsy DeviceSummary page 1…ies (2 1 CFR 870.4400) Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the Rubicor Breast Biopsy Device (K020047) Intended Use: The Rubicor EncapsuleTMBreast Biopsy Device is intended for diagnostic sampling of breast tissue during breast bi… | 2002 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2006 | Not classified | Z-0715-06 | Other | Devices' 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 9 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K030049 (Rubicor Medical, Inc., 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Rubicor EncapsuleTMBreast Biopsy Device is intended for diagnostic sampling of
breast tissue during breast biopsy procedure.
The Rubicor EncapsuleTMBreast Biopsy Device is to be used for diagnostic purposes only
and is not intended for therapeutic uses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023601: Rubicor Encapsule Breast Biopsy Device, Model 30086.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023601
Report an extraction error
Are you the manufacturer?
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