510(k) Report

510(k) · Cleared

Cleared

Caris Minitome Biopsy Instrument

K020024510(k) TraditionalCleared Apr 3, 200290-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

Artemis Medical, Inc. · KNW Instrument, Biopsy

Cleared on Apr 3, 2002 as substantially equivalent to K983296 (United States Surgical, A Division of Tyco Healthc, 1999) and 6 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1987.

Decided
Apr 3, 2002
Review
90 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K871390 (1987). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 3 other ancestors1999: 1 other ancestor1997: 1 other ancestorK871390 · Bard Biopty Biopsy System · C.R. Bard, Inc. · 1987K963825 · Auto Suture* Abbi* System · United States Surgical, A Division of Tyco Healthc · 1996K983296 · Auto Suture Abbi System · United States Surgical, A Division of Tyco Healthc · 19991985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors K983296 · Auto Suture Abbi System · United States Surgical, A Division of Tyco Healthc · 1999K963825 · Auto Suture* Abbi* System · United States Surgical, A Division of Tyco Healthc · 1996K871390 · Bard Biopty Biopsy System · C.R. Bard, Inc. · 19870
  1. Root · 3 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
  2. 2 generations backK963825 Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc · 1996
  3. 1 generation backK983296 Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc · 1999
  4. This deviceK020024 Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K871390Bard Biopty Biopsy SystemC.R. Bard, Inc.1987—
−2K963825Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc1996—
−1K983296Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc1999—
0 (this device)K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200130
FIG. 1 — Lineage of K020024, 1987–2002Source: 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? (7)

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
*K983296Auto Suture Abbi System
Summary page 1
…ological characteristics, and is substantially equivalent to the following predicate breast biopsy devices: « Auto Suture ABBI System, by United States Surgical Corp. (#K983296, K963825) « Site Select Breast Biopsy Device, by Imagyn Surgical (#K993936) e BMI Mammotome, by Biopsys Medical (now Ethicon/Jo…
United States Surgical, A Division of Tyco Healthc1999—
*K963825Auto Suture* Abbi* System
Summary page 1
…characteristics, and is substantially equivalent to the following predicate breast biopsy devices: « Auto Suture ABBI System, by United States Surgical Corp. (#K983296, K963825) « Site Select Breast Biopsy Device, by Imagyn Surgical (#K993936) e BMI Mammotome, by Biopsys Medical (now Ethicon/Johnson & J…
United States Surgical, A Division of Tyco Healthc1996—
*K99393615MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM…
Summary page 1
…redicate breast biopsy devices: « Auto Suture ABBI System, by United States Surgical Corp. (#K983296, K963825) « Site Select Breast Biopsy Device, by Imagyn Surgical (#K993936) e BMI Mammotome, by Biopsys Medical (now Ethicon/Johnson & Johnson) (#K970565) e Mammotome Hand Held Probe, by Ethicon Endo-Su…
Imagyn Surgical1999—
*K970565Mammotome Biopsy Probe and Housing (Mammotome)
Summary page 1
…gical Corp. (#K983296, K963825) « Site Select Breast Biopsy Device, by Imagyn Surgical (#K993936) e BMI Mammotome, by Biopsys Medical (now Ethicon/Johnson & Johnson) (#K970565) e Mammotome Hand Held Probe, by Ethicon Endo-Surgery (#K003297) e En Bloc Biopsy System, by Neothermia (#K003190) ¢ Core Tiss…
Biopsys Medical, Inc.1997—
*K003297Mammotome Hand Held Probe, Model MHH8
Summary page 1
…ce, by Imagyn Surgical (#K993936) e BMI Mammotome, by Biopsys Medical (now Ethicon/Johnson & Johnson) (#K970565) e Mammotome Hand Held Probe, by Ethicon Endo-Surgery (#K003297) e En Bloc Biopsy System, by Neothermia (#K003190) ¢ Core Tissue Biopsy System, by Sanarus (#K003528) Intended Use: The Caris…
Ethicon Endo-Surgery, Inc.2001—
*K003190EN Bloc Biopsy System
Summary page 1
…by Biopsys Medical (now Ethicon/Johnson & Johnson) (#K970565) e Mammotome Hand Held Probe, by Ethicon Endo-Surgery (#K003297) e En Bloc Biopsy System, by Neothermia (#K003190) ¢ Core Tissue Biopsy System, by Sanarus (#K003528) Intended Use: The Caris™ MiniTome Biopsy Instrument is indicated to provid…
Neothermia Corp.200111
*K003528Sanarus Core Tissue Biopsy System
Summary page 1
…(#K970565) e Mammotome Hand Held Probe, by Ethicon Endo-Surgery (#K003297) e En Bloc Biopsy System, by Neothermia (#K003190) ¢ Core Tissue Biopsy System, by Sanarus (#K003528) Intended Use: The Caris™ MiniTome Biopsy Instrument is indicated to provide breast tissue samples for histologic examination w…
Endocare, Inc.2001—

Also cleared against K983296: 3 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 15 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K983296.

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 Caris™ MiniTome Biopsy Instrument is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of an 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…

Read the full statement (101 words)

The Caris™ MiniTome Biopsy Instrument is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of an 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 its 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K983296

3 other devices cite the same predicate.

  • K040087RabbitScion International, Inc. · 2004
  • K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302Neothermia Corp. · 2002
  • K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001

More from Artemis Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K03221714G Cormark Biopsy Site IdentifierArtemis Medical, Inc. · 2003
  • K003777Caris Site MarkerArtemis Medical, Inc. · 2001

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/K020024 · printed Nov 3, 2026

Cite this page

510(k) Report. “K020024: Caris Minitome Biopsy Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020024

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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