510(k) Report

510(k) · Cleared

Cleared

Bard Biopty Biopsy System

K871390510(k) TraditionalCleared Jun 5, 198759-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

C.R. Bard, Inc. · KNW Instrument, Biopsy

Cleared on Jun 5, 1987 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 39 later devices descend from it.

Decided
Jun 5, 1987
Review
59 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

39 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1996: 3 descendants cleared2004: 2 descendants cleared2005: 3 descendants cleared2011: 2 descendants cleared2019: 3 descendants cleared1998: 2 descendants cleared2013: 2 descendants cleared1999: 2 descendants cleared2002: 2 descendants cleared2010: 1 descendant cleared2026: 2 descendants cleared2001: 1 descendant cleared2007: 2 descendants cleared2014: 2 descendants cleared2018: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2021: 2 descendants cleared2015: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
  2. Descendant · cites it directly · 27 of its ownK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
  3. Descendant · 2 generations on · 25 of its ownK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
  4. Descendant · 2 generations on · 24 of its ownK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
  5. Descendant · 2 generations on · 20 of its ownK990839 Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
  6. Descendant · 3 generations on · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

1996: 31998: 21999: 22001: 12002: 22004: 22005: 32007: 22010: 12011: 22013: 22014: 22015: 12018: 12019: 32020: 12021: 22022: 12023: 22024: 12025: 12026: 2
1996high 3 (1996) · low 0 (1997)2026

Most influential descendants

Showing 5 of 39 · See all
  • K962969Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996 · cites it directly27descendants
  • K982085Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy InstrumentMedical Device Technologies, Inc. · 1998 · 2 generations on25descendants
  • K982960Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy InstrumentMedical Device Technologies, Inc. · 1998 · 2 generations on24descendants
  • K990839Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999 · 2 generations on20descendants
  • K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L. · 2005 · 3 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K871390Bard Biopty Biopsy SystemC.R. Bard, Inc.1987—
+1K962969Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc.1996—
+2K982085Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy…Medical Device Technologies, Inc.1998—
+2K982960Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy InstrumentMedical Device Technologies, Inc.19982
+2K990839Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc.1999—
+3K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut…Sterylab S.R.L.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
199820
199920
200110
200220
200420
200530
200720
201010
201120
201320
201420
201510
201810
201930
202010
202120
202210
202320
202410
202510
202620
FIG. 1 — Lineage of K871390, 1987–2026Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K962969Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc.199627
K963825Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc19966
K962077Bard Biopty-Cut Biopsy Needle/with SpacerC.R. Bard, Inc.19962
K041544Cook Sidearm Core Tissue Biopsy DeviceUrological, Inc.20041

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, K962969 (Medical Device Technologies, Inc., 1996) has gone furthest, with 27 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 C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

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/K871390 · printed Nov 5, 2026

Cite this page

510(k) Report. “K871390: Bard Biopty Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871390

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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