510(k) Report

510(k) · Cleared

Cleared

Rabbit

K040087510(k) TraditionalCleared Apr 1, 200476-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

Scion International, Inc. · KNW Instrument, Biopsy

Cleared on Apr 1, 2004 as substantially equivalent to K983296 (United States Surgical, A Division of Tyco Healthc, 1999) and 2 other predicates after a 76-day review. Its family tree reaches back 4 generations to 1987.

Decided
Apr 1, 2004
Review
76 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K871390 (1987). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1998: 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 · 1999K011575 · 22MM Siteselect Breast Biopsy Device Model SSD022 · Imagyn Surgical · 200119851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors K011575 · 22MM Siteselect Breast Biopsy Device Model SSD022 · Imagyn Surgical · 2001K983296 · 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 · 4 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
  2. 3 generations backK963825 Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc · 1996
  3. 2 generations backK983296 Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc · 1999
  4. 1 generation backK011575 22MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001
  5. This deviceK040087 RabbitScion International, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K871390Bard Biopty Biopsy SystemC.R. Bard, Inc.1987—
−3K963825Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc1996—
−2K983296Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc1999—
−1K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical2001—
0 (this device)K040087RabbitScion International, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200110
FIG. 1 — Lineage of K040087, 1987–2004Source: 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
*K983296Auto Suture Abbi System
Summary page 1
…iopsy Devices to which substantial equivalence is claimed: 5 10(K) ft Device Manufacture K983296 Auto Suture ABBI System U.S. Surgical Corporation K01 1575 SiteSelect Breast…
United States Surgical, A Division of Tyco Healthc1999—
*K01157522MM Siteselect Breast Biopsy Device Model SSD022
Summary page 1
…Device Manufacture K983296 Auto Suture ABBI System U.S. Surgical Corporation K01 1575 SiteSelect Breast Biopsy Device Imagyn Surgical K003297 Mammotomne…
Imagyn Surgical2001—
*K003297Mammotome Hand Held Probe, Model MHH8
Summary page 1
…ture ABBI System U.S. Surgical Corporation K01 1575 SiteSelect Breast Biopsy Device Imagyn Surgical K003297 Mammotomne Eth icon Device Description: The Candidate Device is a coaxial breast biopsy…
Ethicon Endo-Surgery, 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 17 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • None of the 7 ancestors has a recall.
  • 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 Rabbit 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 K983296

3 other devices cite the same predicate.

  • K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002
  • 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 Scion International, Inc.

4 FDA decisions under this applicant name. See the company

  • K973698Scion Balloon ElevatorScion International, Inc. · 1998
  • K973652Duoclipper Titanium ClipsScion International, Inc. · 1998
  • K963006Scion Saphenous Vein Harvesting SystemScion International, Inc. · 1996

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/K040087 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040087: Rabbit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040087

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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