510(k) Report

510(k) · Cleared

Cleared

Encor Breast Biopsy System

K093512510(k) TraditionalCleared Nov 20, 20097-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

Senorx, Inc. · KNW Instrument, Biopsy

Cleared on Nov 20, 2009 as substantially equivalent to K040842 (Senorx, Inc., 2004) and 3 other predicates after a 7-day review. Its family tree reaches back 2 generations to 1999. 5 later devices descend from it.

Decided
Nov 20, 2009
Review
7 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K991980 (1999). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor2023: 1 descendant cleared2018: 1 descendant cleared2011: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK991980 · Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch, · Ethicon Endo-Surgery, Inc. · 1999K030472 · Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System · Ethicon Endo-Surgery, Inc. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K030472 · Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System · Ethicon Endo-Surgery, Inc. · 2003K991980 · Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch, · Ethicon Endo-Surgery, Inc. · 19990
  1. Root · 2 generations backK991980 Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH…Ethicon Endo-Surgery, Inc. · 1999
  2. 1 generation backK030472 Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003
  3. This deviceK093512 Encor Breast Biopsy SystemSenorx, Inc. · 2009
  4. Descendant · cites it directly · 3 of its ownK111100 Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011
  5. Descendant · cites it directly · 2 of its ownK233220 EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast…Senorx, Inc. · 2023
  6. Descendant · 2 generations on · 1 of its ownK252681 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025 · Recalled
  7. Descendant · 3 generations on · 0 of its ownK262571 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  8. Descendant · cites it directly · 0 of its ownK171890 BEXCORE Breast Biopsy System, Biopsy NeedleMedical Park Co., Ltd. · 2018

Most influential descendants

Showing 5 of 5 · See all
  • K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011 · cites it directly3descendants
  • K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc. · 2023 · cites it directly2descendants
  • K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025 · 2 generations on1descendant
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026 · 3 generations on0descendants
  • K171890BEXCORE Breast Biopsy System, Biopsy NeedleMedical Park Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K991980Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster…Ethicon Endo-Surgery, Inc.1999—
−1K030472Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc.2003—
0 (this device)K093512Encor Breast Biopsy SystemSenorx, Inc.2009—
+1K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc.2011—
+1K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc.2023—
+2K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.20251
+3K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.2026—
+1K171890BEXCORE Breast Biopsy System, Biopsy NeedleMedical Park Co., Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201810
202310
202510
202610
FIG. 1 — Lineage of K093512, 1999–2026Source: 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? (4)

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
*K040842Senorx Biopsy Device II
Summary page 1
…psy device Classification name Gastroenterology-urology biopsy instrument Classification regulation 21 CFR 876.1075 KNW Predicate devices K040842 (4/30/2004); K003297 (1/18/2001); K030472 (10/9/2003); K051158 (5/16/2005) Description…
Senorx, Inc.200410
*K003297Mammotome Hand Held Probe, Model MHH8
Summary page 1
…ation name Gastroenterology-urology biopsy instrument Classification regulation 21 CFR 876.1075 KNW Predicate devices K040842 (4/30/2004); K003297 (1/18/2001); K030472 (10/9/2003); K051158 (5/16/2005) Description Modify indications…
Ethicon Endo-Surgery, Inc.2001—
*K030472Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System
Summary page 1
…stroenterology-urology biopsy instrument Classification regulation 21 CFR 876.1075 KNW Predicate devices K040842 (4/30/2004); K003297 (1/18/2001); K030472 (10/9/2003); K051158 (5/16/2005) Description Modify indications for use to add for u…
Ethicon Endo-Surgery, Inc.2003—
*K051158Encor 7 Gauge
Summary page 1
…y biopsy instrument Classification regulation 21 CFR 876.1075 KNW Predicate devices K040842 (4/30/2004); K003297 (1/18/2001); K030472 (10/9/2003); K051158 (5/16/2005) Description Modify indications for use to add for use with palpable abno…
Senorx, Inc.200510

Also cleared against K040842: 1 other device →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc.20113
K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc.20232
K171890BEXCORE Breast Biopsy System, Biopsy NeedleMedical Park Co., Ltd.20180

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 10 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K111100 (C.R. Bard, Inc., 2011) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K040842.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 EnCor Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. * It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. * It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from…

Read the full statement (204 words)

The EnCor Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.

* It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

* It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the EnCor Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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 K040842

1 other device cites the same predicate.

  • K072541Senosonix Ultrasound Breast Biopsy SystemSenorx, Inc. · 2007

More from Senorx, Inc.

30 FDA decisions under this applicant name. See the company

  • K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast…Senorx, Inc. · 2023
  • K210654EnCor Breast Biopsy Probe with Rinse TubeSenorx, Inc. · 2021
  • K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. · 2016
  • K131654Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue MarkerSenorx, Inc. · 2013
  • K092323Contura Cavity Maintenance CatheterSenorx, Inc. · 2009

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/K093512 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093512: Encor Breast 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/K093512

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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