510(k) Report

510(k) · Cleared

Cleared

Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012

K080171510(k) TraditionalCleared Mar 6, 200842-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 Mar 6, 2008 as substantially equivalent to K051581 (Sanarus Medical, Inc., 2005) after a 42-day review. Its family tree reaches back 6 generations to 2001.

Decided
Mar 6, 2008
Review
42 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K003528 (2001). No later device cites it as a predicate yet.

K003528 · Sanarus Core Tissue Biopsy System · Endocare, Inc. · 2001K021137 · Sanarus Centrica Core Tissue Biopsy System · Sanarus Medical, Inc. · 2002K022879 · Modification to Sanarus Centrica Core Tissue Biopsy · Sanarus Medical, Inc. · 2002 · recalledK032506 · Sanarus Centrica II Rotational Core Biopsy System · Sanarus Medical, Inc. · 2003K042136 · Sanarus Cassi Rotational Core Biopsy System · Sanarus Medical, Inc. · 2004K051581 · Sanarus Cassi II Rotational Core Biopsy System, Model CS2000 · Sanarus Medical, Inc. · 2005200020022004200620082010
K051581 · Sanarus Cassi II Rotational Core Biopsy System, Model CS2000 · Sanarus Medical, Inc. · 2005K042136 · 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 · 6 generations backK003528 Sanarus Core Tissue Biopsy SystemEndocare, Inc. · 2001
  2. 5 generations backK021137 Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc. · 2002
  3. 4 generations backK022879 Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002 · Recalled
  4. 3 generations backK032506 Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003
  5. 2 generations backK042136 Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004
  6. 1 generation backK051581 Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005
  7. This deviceK080171 Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012Sanarus Medical, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K003528Sanarus Core Tissue Biopsy SystemEndocare, Inc.2001—
−5K021137Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc.2002—
−4K022879Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc.20021
−3K032506Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc.2003—
−2K042136Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc.2004—
−1K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc.2005—
0 (this device)K080171Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012Sanarus Medical, Inc.2008—
FIG. 1 — Lineage of K080171, 2001–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000
Summary page 2
…re Biopsy System is substantially equivalent to the Cassi II Rotational Core Biopsy System that was determined to be substantially equivalent on July 27, 2005 (reference K051581). The Sanarus InCore Rotational Core Biopsy System has the same indications for use and technological characteristics as the pre…
Sanarus Medical, Inc.2005—

Also cleared against K051581: 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)

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 7 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K051581.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 K051581

2 other devices cite the same predicate.

  • K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird…Transmed7, LLC · 2018
  • K123606Cassi II Rotational Core Biopsy System; Cassi Quadpoint DisposableScion Medical Technologies, LLC · 2013

More from Sanarus Medical, Inc.

14 FDA decisions under this applicant name. See the company

  • 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
  • K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus 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/K080171 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080171: Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080171

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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