510(k) Report

510(k) · Cleared

Cleared

EleVation Breast Biopsy System

K211933510(k) SpecialCleared Jul 15, 202123-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

Bard Peripheral Vascular · KNW Instrument, Biopsy

Cleared on Jul 15, 2021 as substantially equivalent to K192948 (Bard Peripheral Vascular, Inc., 2019) after a 23-day review. Its family tree reaches back 5 generations to 2006.

Decided
Jul 15, 2021
Review
23 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K062832 (2006). 7 ancestors in all, the oldest K003297 (2001). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2001: 1 other ancestorK062832 · Vacora 14G Biopsy Probes, Models VB14116, VB14138 · C.R. Bard, Inc. · 2006 · recalledK082681 · Vacora Vacuum Assisted Biopsy System · C.R. Bard, Inc. · 2008 · recalledK093068 · Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105US · C.R. Bard, Inc. · 2009K103359 · Finesse Ultra Breast Biopsy System Driver (Blue, Pink) · C.R. Bard, Inc. · 2010K192948 · EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G · Bard Peripheral Vascular, Inc. · 201920002005201020152020
Other ancestors, by generation 4 generations back: 2 other ancestors K192948 · EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G · Bard Peripheral Vascular, Inc. · 2019K103359 · Finesse Ultra Breast Biopsy System Driver (Blue, Pink) · C.R. Bard, Inc. · 2010K093068 · Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105US · C.R. Bard, Inc. · 2009K082681 · Vacora Vacuum Assisted Biopsy System · C.R. Bard, Inc. · 2008 · recalledK062832 · Vacora 14G Biopsy Probes, Models VB14116, VB14138 · C.R. Bard, Inc. · 2006 · recalled−50
  1. Root · 5 generations backK062832 Vacora 14G Biopsy Probes, Models VB14116, VB14138C.R. Bard, Inc. · 2006 · Recalled
  2. 4 generations backK082681 Vacora Vacuum Assisted Biopsy SystemC.R. Bard, Inc. · 2008 · Recalled
  3. 3 generations backK093068 Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe…C.R. Bard, Inc. · 2009
  4. 2 generations backK103359 Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc. · 2010
  5. 1 generation backK192948 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G…Bard Peripheral Vascular, Inc. · 2019
  6. This deviceK211933 EleVation Breast Biopsy SystemBard Peripheral Vascular · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K062832Vacora 14G Biopsy Probes, Models VB14116, VB14138C.R. Bard, Inc.20061
−4K082681Vacora Vacuum Assisted Biopsy SystemC.R. Bard, Inc.20084
−3K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk…C.R. Bard, Inc.2009—
−2K103359Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc.2010—
−1K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation…Bard Peripheral Vascular, Inc.2019—
0 (this device)K211933EleVation Breast Biopsy SystemBard Peripheral Vascular2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
FIG. 1 — Lineage of K211933, 2006–2021Source: 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? (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
*K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast…
Summary page 4
…Code KNW) Review Panel: Gastroenterology/Urology Regulation Number: 21 CFR 876.1075 3. Predicate Device: ELEVATIONTM Breast Biopsy System (K192948; cleared November 7, 2019) 4. Device Description: The ELEVATIONTM Breast Biopsy System is a handheld, self-contained, single ins…
Bard Peripheral Vascular, Inc.2019—

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 1.7 years on median.
  • 2 of the 7 ancestors have a recall of any class.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 EleVation Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities. The instrument 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…

Read the full statement (107 words)

The EleVation Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities. The instrument 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 summary.

More from Bard Peripheral Vascular

41 FDA decisions under this applicant name. See the company

  • K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular · 2022
  • P060002/S040Flair Endovascular Stent GraftBard Peripheral Vascular · 2018
  • P060002/S038Flair Endovascular Stent GraftBard Peripheral Vascular · 2017
  • P060002/S039Flair Endovascular Stent GraftBard Peripheral Vascular · 2017
  • P060002/S036Flair Endovascular Stent GraftBard Peripheral Vascular · 2016

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/K211933 · printed Nov 6, 2026

Cite this page

510(k) Report. “K211933: EleVation Breast Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211933

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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