510(k) Report

510(k) · Cleared

Cleared

Vacuum Assisted Core Biopsy Device

K034021510(k) TraditionalCleared Sep 8, 2004259-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

Suros Surgical Systems, Inc. · KNW Instrument, Biopsy

Cleared on Sep 8, 2004 after a 259-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.

Decided
Sep 8, 2004
Review
259 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2015: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2019: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK034021 Vacuum Assisted Core Biopsy DeviceSuros Surgical Systems, Inc. · 2004
  2. Descendant · cites it directly · 7 of its ownK093068 Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe…C.R. Bard, Inc. · 2009
  3. Descendant · 2 generations on · 3 of its ownK112411 Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012
  4. Descendant · 3 generations on · 2 of its ownK153709 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy…Devicor Medical Products, Inc. · 2016
  5. Descendant · 2 generations on · 2 of its ownK103359 Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc. · 2010
  6. Descendant · 3 generations on · 1 of its ownK192948 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G…Bard Peripheral Vascular, Inc. · 2019

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12012: 12015: 12016: 12018: 12019: 12021: 12022: 1
2009high 1 (2009) · low 0 (2011)2026

Most influential descendants

Showing 5 of 9 · See all
  • K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USC.R. Bard, Inc. · 2009 · cites it directly7descendants
  • K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012 · 2 generations on3descendants
  • K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…Devicor Medical Products, Inc. · 2016 · 3 generations on2descendants
  • K103359Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc. · 2010 · 2 generations on2descendants
  • K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast…Bard Peripheral Vascular, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K034021Vacuum Assisted Core Biopsy DeviceSuros Surgical Systems, Inc.2004—
+1K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk…C.R. Bard, Inc.2009—
+2K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc.2012—
+3K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G…Devicor Medical Products, Inc.2016—
+2K103359Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc.2010—
+3K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation…Bard Peripheral Vascular, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201210
201510
201610
201810
201910
202110
202210
FIG. 1 — Lineage of K034021, 2004–2022Source: 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 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? (9)

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

NumberDeviceApplicantDecidedDescendants
K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USC.R. Bard, Inc.20097
K150088Evacore Fully Disposable Vacuum Assist Biopsy DevicePin-Point Care Corp.20150

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?

  • Of its descendants, K093068 (C.R. Bard, Inc., 2009) has gone furthest, with 7 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?

To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymrph nodes. When used for breast biopsy, the product is for diagnosis only.

Indications for use as stated in the FDA 510(k) statement.

More from Suros Surgical Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K062528Tissue Site Marking SystemSuros Surgical Systems, Inc. · 2007
  • K042290Vacuum Assisted Core Biopsy DeviceSuros Surgical Systems, Inc. · 20044 recalls

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/K034021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K034021: Vacuum Assisted Core Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K034021

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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