510(k) Report

510(k) · Cleared

Cleared

Sanarus Centrica Core Tissue Biopsy System

K021137510(k) TraditionalCleared Jun 26, 200278-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

Sanarus Medical, Inc. · KNW Instrument, Biopsy

Cleared on Jun 26, 2002 as substantially equivalent to K003528 (Endocare, Inc., 2001) after a 78-day review. Its family tree reaches back 1 generation to 2001. 11 later devices descend from it.

Decided
Jun 26, 2002
Review
78 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003528 (2001). 11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2005: 2 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2008: 1 descendant cleared2007: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant clearedK003528 · Sanarus Core Tissue Biopsy System · Endocare, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants K003528 · Sanarus Core Tissue Biopsy System · Endocare, Inc. · 20010+5
  1. Root · 1 generation backK003528 Sanarus Core Tissue Biopsy SystemEndocare, Inc. · 2001
  2. This deviceK021137 Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc. · 2002
  3. Descendant · cites it directly · 10 of its ownK022879 Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 9 of its ownK032506 Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003
  5. Descendant · 3 generations on · 8 of its ownK042136 Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004
  6. Descendant · 4 generations on · 4 of its ownK051581 Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005
  7. Descendant · 4 generations on · 3 of its ownK053151 Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12005: 22007: 12008: 12013: 12014: 12016: 12018: 1
2002high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 11 · See all
  • K022879Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002 · cites it directly10descendants
  • K032506Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003 · 2 generations on9descendants
  • K042136Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004 · 3 generations on8descendants
  • K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005 · 4 generations on4descendants
  • K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003528Sanarus Core Tissue Biopsy SystemEndocare, Inc.2001—
0 (this device)K021137Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc.2002—
+1K022879Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc.20021
+2K032506Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc.2003—
+3K042136Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc.2004—
+4K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc.2005—
+4K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200520
200710
200810
201310
201410
201610
201810
FIG. 1 — Lineage of K021137, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K003528Sanarus Core Tissue Biopsy System
Our reading of the summary gave K013528, FDA’s number for Crystal 5000 Phases Array TMJ Coil (Usa Instruments, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Sanarus Core Tissue Biopsy System”.
Endocare, Inc.2001—

Also cleared against K003528: 1 other device →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K022879Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc.200210

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?

  • Its one ancestor has no recall.
  • Of its descendants, K022879 (Sanarus Medical, Inc., 2002) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K003528.

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 device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. The device is also 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…

Read the full statement (131 words)

The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device is also 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 K003528

1 other device cites the same predicate.

  • K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002

More from Sanarus Medical, Inc.

14 FDA decisions under this applicant name. See the company

  • K080171Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012Sanarus Medical, Inc. · 2008
  • K073533Sanarus V2 Treatment SystemSanarus Medical, Inc. · 2008
  • K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Sanarus Medical, Inc. · 2007
  • K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
  • K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005

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/K021137 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021137: Sanarus Centrica Core Tissue Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021137

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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