510(k) Report

510(k) · Cleared

Recalled · 2010

Vacuum Assisted Core Biopsy Device

K010400510(k) TraditionalCleared Jul 24, 2001162-day reviewClass II21 CFR 876.1075Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Promex, Inc. · KNW Instrument, Biopsy

Cleared on Jul 24, 2001 after a 162-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it. It has been recalled 5 times.

Decided
Jul 24, 2001
Review
162 days
Class
Class II
Product code
KNW
Recalls
5
Predicates
0

5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2018: 1 descendant cleared2005: 1 descendant cleared2007: 1 descendant cleared2014: 1 descendant cleared200020052010201520202025
  1. This deviceK010400 Vacuum Assisted Core Biopsy DevicePromex, Inc. · 2001
  2. Descendant · cites it directly · 4 of its ownK024089 Vacuflash Biopsy SystemBip USA, Inc. · 2003
  3. Descendant · 2 generations on · 3 of its ownK053151 Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005
  4. Descendant · 3 generations on · 1 of its ownK071048 Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007
  5. Descendant · 2 generations on · 0 of its ownK173316 SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU…Transmed7, LLC · 2018
  6. Descendant · 4 generations on · 0 of its ownK133702 Presto Breast Biopsy DeviceSontina Medical, LLC · 2014

Most influential descendants

Showing 5 of 5 · See all
  • K024089Vacuflash Biopsy SystemBip USA, Inc. · 2003 · cites it directly4descendants
  • K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005 · 2 generations on3descendants
  • K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007 · 3 generations on1descendant
  • K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC · 2018 · 2 generations on0descendants
  • K133702Presto Breast Biopsy DeviceSontina Medical, LLC · 2014 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010400Vacuum Assisted Core Biopsy DevicePromex, Inc.2001—
+1K024089Vacuflash Biopsy SystemBip USA, Inc.2003—
+2K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc.2005—
+3K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc.2007—
+2K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft…Transmed7, LLC2018—
+4K133702Presto Breast Biopsy DeviceSontina Medical, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200710
201410
201810
FIG. 1 — Lineage of K010400, 2001–2018Source: 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K024089Vacuflash Biopsy SystemBip USA, Inc.20034

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 11, 2010Not classifiedZ-2285-2010PackagingThe firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.
Feb 1, 2010Not classifiedZ-1160-2010Employee errorThe product is labeled as ATEC0909-12 but it actually contains 0909-20.
Sep 22, 2008Not classifiedZ-0275-2009Process controlThe distal tip of the needle may become detached and remain in the patient, requiring surgical removal.
Dec 15, 2006Not classifiedZ-0362-2007OtherThe handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
May 25, 2006Not classifiedZ-1160-06OtherLack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K024089 (Bip USA, Inc., 2003) has gone furthest, with 4 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)—

More from Promex, Inc.

18 FDA decisions under this applicant name. See the company

  • K023450Biopsy Site Tissue Marker DevicePromex, Inc. · 2002
  • K022634CO-Axial Introducer NeedlePromex, Inc. · 20026 recalls
  • K011270Automated Core Biopsy DevicePromex, Inc. · 2001
  • K001132Bone Biopsy NeedlePromex, Inc. · 2000
  • K994272Automated Core Biopsy DevicePromex, Inc. · 2000

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/K010400 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010400: Vacuum Assisted Core Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010400

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026