510(k) Report

510(k) · Cleared

Cleared

Rubicor Magic Breast Biopsy Device

K053151510(k) TraditionalCleared Nov 18, 20058-day reviewClass II21 CFR 876.1075

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

Rubicor Medical, Inc. · KNW Instrument, Biopsy

Cleared on Nov 18, 2005 as substantially equivalent to K991980 (Ethicon Endo-Surgery, Inc., 1999) and 2 other predicates after an 8-day review. Its family tree reaches back 5 generations to 2001. 3 later devices descend from it.

Decided
Nov 18, 2005
Review
8 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K003528 (2001). 10 ancestors in all, the oldest K970565 (1997). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1999: 1 other ancestor2001: 2 other ancestors1997: 1 other ancestor2018: 1 descendant cleared2007: 1 descendant cleared2014: 1 descendant clearedK003528 · Sanarus Core Tissue Biopsy System · Endocare, Inc. · 2001×2: 2 generations cleared close together, K021137 (2002), K022879 (2002) K032506 · Sanarus Centrica II Rotational Core Biopsy System · Sanarus Medical, Inc. · 2003K042136 · Sanarus Cassi Rotational Core Biopsy System · Sanarus Medical, Inc. · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K042136 · Sanarus Cassi Rotational Core Biopsy System · Sanarus Medical, Inc. · 2004K032506 · Sanarus Centrica II Rotational Core Biopsy System · Sanarus Medical, Inc. · 2003K022879 · Modification to Sanarus Centrica Core Tissue Biopsy · Sanarus Medical, Inc. · 2002 · recalledK021137 · Sanarus Centrica Core Tissue Biopsy System · Sanarus Medical, Inc. · 2002K003528 · Sanarus Core Tissue Biopsy System · Endocare, Inc. · 2001−50
  1. Root · 5 generations backK003528 Sanarus Core Tissue Biopsy SystemEndocare, Inc. · 2001
  2. 4 generations backK021137 Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc. · 2002
  3. 3 generations backK022879 Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002 · Recalled
  4. 2 generations backK032506 Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003
  5. 1 generation backK042136 Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004
  6. This deviceK053151 Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005
  7. Descendant · cites it directly · 1 of its ownK071048 Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007
  8. Descendant · cites it directly · 0 of its ownK173316 SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU…Transmed7, LLC · 2018
  9. Descendant · 2 generations on · 0 of its ownK133702 Presto Breast Biopsy DeviceSontina Medical, LLC · 2014

Most influential descendants

Showing 3 of 3 · See all
  • K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007 · cites it directly1descendant
  • K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC · 2018 · cites it directly0descendants
  • K133702Presto Breast Biopsy DeviceSontina Medical, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K003528Sanarus Core Tissue Biopsy SystemEndocare, Inc.2001—
−4K021137Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc.2002—
−3K022879Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc.20021
−2K032506Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc.2003—
−1K042136Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc.2004—
0 (this device)K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc.2005—
+1K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc.2007—
+1K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft…Transmed7, LLC2018—
+2K133702Presto Breast Biopsy DeviceSontina Medical, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200120
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201410
201810
FIG. 1 — Lineage of K053151, 2001–2018Source: 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 KNW? 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 KNW device

  1. #1 K260572 Marrow Marxmanscore 14.5 · 10 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
*K991980Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and…
Summary page 1
…1 CFR 876.1075) Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the Ethicon Mammotome® Hand-Held System (K991980), the Sanarus Cassie Rotational Core Biopsy System (K042136), and the BIP VacuFlash® Biopsy System (K024089). Device Description…
Ethicon Endo-Surgery, Inc.1999—
*K042136Sanarus Cassi Rotational Core Biopsy System
Summary page 1
…bstantially equivalent in intended use and/or method of operation to the Ethicon Mammotome® Hand-Held System (K991980), the Sanarus Cassie Rotational Core Biopsy System (K042136), and the BIP VacuFlash® Biopsy System (K024089). Device Description: The Rubicor Magic Breast Biopsy Device is a sterile, sing…
Sanarus Medical, Inc.2004—
*K024089Vacuflash Biopsy System
Summary page 1
…thod of operation to the Ethicon Mammotome® Hand-Held System (K991980), the Sanarus Cassie Rotational Core Biopsy System (K042136), and the BIP VacuFlash® Biopsy System (K024089). Device Description: The Rubicor Magic Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working e…
Bip USA, Inc.2003—

Also cleared against K991980: 5 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc.20071
K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC20180

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • Of its descendants, K071048 (Rubicor Medical, Inc., 2007) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K991980.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNW

12in 2025

2007: 62008: 42009: 62010: 32011: 102012: 72013: 32014: 82015: 102016: 92017: 82018: 72019: 52020: 82021: 92022: 82023: 72024: 52025: 122026 (partial year): 7
2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007: 94 days median2008: 53 days median2009: 35 days median2010: 57 days median2011: 64 days median2012: 94 days median2013: 100 days median2014: 95 days median2015: 106 days median2016: 127 days median2017: 90 days median2018: 71 days median2019: 94 days median2020: 92 days median2021: 54 days median2022: 203 days median2023: 164 days median2024: 114 days median2025: 178 days median2026 (partial year): 29 days median
2007high 203 (2022) · low 35 (2009)2026

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

Recalls per year · KNW

1in 2024

2007: 12008: 72009: 32010: 22011: 52012: 12013: 1, 1 Class I2014: 32016: 52017: 12019: 42021: 32022: 32023: 22024: 12026 (partial year): 4, 3 Class I
2007high 7 (2008) · low 0 (2015)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · KNW

1,667in 2025

2007: 7662008: 3632009: 3512010: 1622011: 672012: 932013: 982014: 1932015: 5912016: 2972017: 7602018: 1,0122019: 4,1952020: 5,1202021: 1,0202022: 5352023: 9312024: 1,2832025: 1,667
2007high 5,120 (2020) · low 67 (2011)2025

MAUDE reports naming product code KNW, 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
20076941766
20084537363
20096353351
20103572162
20111064567
2012794193
201331001 (1)98
20148953193
2015101060591
201691275297
20178901760
201877101,012
201959444,195
202089205,120
202195431,020
202282033535
202371642931
2024511411,283
20251217801,667
20267294 (3)—

What is it indicated for?

The Rubicor Magic TM 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 Rubicor Magic TM 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…

Read the full statement (137 words)

The Rubicor Magic TM 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 Rubicor Magic TM 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 K991980

5 other devices cite the same predicate.

  • K030472Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003
  • K032847Excisor Bioptome, Model 01-0004Acueity, Inc. · 2003
  • K024089Vacuflash Biopsy SystemBip USA, Inc. · 2003
  • K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 20021 recall
  • K013641Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power Cord,Connector Cords and…Senorx, Inc. · 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
  • 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

Recent decisions in KNW

The KNW category page

  • K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd. · 2026
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  • K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
  • K260572Marrow MarxmanMedimetrix, LLC · 2026
  • K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026

https://510kreport.com/device/K053151 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053151: Rubicor Magic Breast Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053151

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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