510(k) Report

510(k) · Cleared

Cleared

Vacuflash Biopsy System

K024089510(k) TraditionalCleared Mar 11, 200390-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

Bip USA, Inc. · KNW Instrument, Biopsy

Cleared on Mar 11, 2003 as substantially equivalent to K970565 (Biopsys Medical, Inc., 1997) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.

Decided
Mar 11, 2003
Review
90 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K970565 (1997). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1999: 1 other ancestor2018: 1 descendant cleared2005: 1 descendant cleared2007: 1 descendant cleared2014: 1 descendant clearedK970565 · Mammotome Biopsy Probe and Housing (Mammotome) · Biopsys Medical, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K970565 · Mammotome Biopsy Probe and Housing (Mammotome) · Biopsys Medical, Inc. · 19970
  1. Root · 1 generation backK970565 Mammotome Biopsy Probe and Housing (Mammotome)Biopsys Medical, Inc. · 1997
  2. This deviceK024089 Vacuflash Biopsy SystemBip USA, Inc. · 2003
  3. Descendant · cites it directly · 3 of its ownK053151 Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005
  4. Descendant · 2 generations on · 1 of its ownK071048 Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007
  5. Descendant · cites it directly · 0 of its ownK173316 SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU…Transmed7, LLC · 2018
  6. Descendant · 3 generations on · 0 of its ownK133702 Presto Breast Biopsy DeviceSontina Medical, LLC · 2014

Most influential descendants

Showing 4 of 4 · See all
  • K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005 · cites it directly3descendants
  • K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007 · 2 generations on1descendant
  • K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC · 2018 · cites it directly0descendants
  • K133702Presto Breast Biopsy DeviceSontina Medical, LLC · 2014 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K970565Mammotome Biopsy Probe and Housing (Mammotome)Biopsys Medical, Inc.1997—
0 (this device)K024089Vacuflash Biopsy SystemBip USA, Inc.2003—
+1K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc.2005—
+2K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc.2007—
+1K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft…Transmed7, LLC2018—
+3K133702Presto Breast Biopsy DeviceSontina Medical, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
201410
201810
FIG. 1 — Lineage of K024089, 1997–2018Source: 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
*K970565Mammotome Biopsy Probe and Housing (Mammotome)Biopsys Medical, Inc.1997—
*K991980Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and…
Summary page 2
…he BIP VacuFlashB Biopsy System is also substantially equivalent to the MammotomeB Hand Held System that was determined to be substantially equivalent on 17 August 1999 (K991980) and the MammotomeB Hand Held 8 Gauge Probe that was determined to be substantially equivalent on 18 January 2001 (K003297). In a…
Ethicon Endo-Surgery, Inc.1999—
*K003297Mammotome Hand Held Probe, Model MHH8
Summary page 2
…be substantially equivalent on 17 August 1999 (K991980) and the MammotomeB Hand Held 8 Gauge Probe that was determined to be substantially equivalent on 18 January 2001 (K003297). In addition, the VacuFlashB Biopsy System is also substantially equivalent to the Suros Surgical Systems ATECB Vacuum Assisted…
Ethicon Endo-Surgery, Inc.2001—
*K010400Vacuum Assisted Core Biopsy Device
Summary page 2
…s also substantially equivalent to the Suros Surgical Systems ATECB Vacuum Assisted Core Biopsy System that was determined to be substantially equivalent on 24 May 2001 (K010400). The BIP VacuFlashB Biopsy System has similar indications for use and technological characteristics as the predicate devices. T…
Promex, Inc.20015

Also cleared against K970565: 2 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc.20053
K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC20180

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?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K053151 (Rubicor Medical, Inc., 2005) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K970565.

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 BIP VacuFlash Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of 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…

Read the full statement (101 words)

The BIP VacuFlash Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of 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.

Also cleared against K970565

2 other devices cite the same predicate.

  • K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002
  • K973496The Auto Suture* Mibb** SystemUnited States Surgical, A Division of Tyco Healthc · 1997

More from Bip USA, Inc.

7 FDA decisions under this applicant name. See the company

  • K934371Bip Multi ModificationBip USA, Inc. · 1994
  • K934370Bip Biopsy Needle ModificationBip USA, Inc. · 19945 recalls
  • K935457Localization Wire or Marker - SurgicalBip USA, Inc. · 19941 recall
  • K925870SpacerBip USA, Inc. · 1993
  • K925875Horizontal Needle Guide AttachmentBip USA, Inc. · 1993

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/K024089 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024089: Vacuflash Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024089

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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