510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Senorx Biopsy Device II

K040842510(k) SpecialCleared Apr 30, 200429-day reviewClass II21 CFR 876.1075Recalls 10

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 Apr 30, 2004 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it. It has been recalled 10 times.

Decided
Apr 30, 2004
Review
29 days
Class
Class II
Product code
KNW
Recalls
10
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2009: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared2011: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK040842 Senorx Biopsy Device IISenorx, Inc. · 2004
  2. Descendant · cites it directly · 5 of its ownK093512 Encor Breast Biopsy SystemSenorx, Inc. · 2009
  3. Descendant · 2 generations on · 3 of its ownK111100 Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011
  4. Descendant · 2 generations on · 2 of its ownK233220 EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast…Senorx, Inc. · 2023
  5. Descendant · 3 generations on · 1 of its ownK252681 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025 · Recalled
  6. Descendant · 4 generations on · 0 of its ownK262571 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12011: 12018: 12023: 12025: 12026: 1
2007high 1 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K093512Encor Breast Biopsy SystemSenorx, Inc. · 2009 · cites it directly5descendants
  • K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011 · 2 generations on3descendants
  • K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc. · 2023 · 2 generations on2descendants
  • K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025 · 3 generations on1descendant
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040842Senorx Biopsy Device IISenorx, Inc.2004—
+1K093512Encor Breast Biopsy SystemSenorx, Inc.2009—
+2K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc.2011—
+2K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc.2023—
+3K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.20251
+4K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201110
201810
202310
202510
202610
FIG. 1 — Lineage of K040842, 2004–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K093512Encor Breast Biopsy SystemSenorx, Inc.20095
K072541Senosonix Ultrasound Breast Biopsy SystemSenorx, Inc.20070

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 3, 2020Class IIZ-1433-2020Component change controlLot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Jan 3, 2020Class IIZ-1431-2020Component change controlLot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Jan 3, 2020Class IIZ-1432-2020Component change controlLot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Jan 3, 2020Class IIZ-1434-2020Component change controlLot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
May 2, 2019Class IIZ-2211-2019Component change controlThere has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019Class IIZ-2214-2019Component change controlThere has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019Class IIZ-2210-2019Component change controlThere has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019Class IIZ-2209-2019Component change controlThere has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019Class IIZ-2212-2019Component change controlThere has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019Class IIZ-2213-2019Component change controlThere has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.

The 5 latest of 10 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K093512 (Senorx, Inc., 2009) has gone furthest, with 5 descendants of its own.

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 SenoRx Biopsy Device II 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.

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 510(k) statement.

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
  • K093512Encor Breast Biopsy SystemSenorx, 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/K040842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040842: Senorx Biopsy Device II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040842

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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