510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument

K982960510(k) TraditionalCleared Sep 23, 199830-day reviewClass II21 CFR 876.1075Recalls 2

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

Medical Device Technologies, Inc. · KNW Instrument, Biopsy

Cleared on Sep 23, 1998 as substantially equivalent to K962969 (Medical Device Technologies, Inc., 1996) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1987. 24 later devices descend from it. It has been recalled 2 times.

Decided
Sep 23, 1998
Review
30 days
Class
Class II
Product code
KNW
Recalls
2
Predicates
2

Its longest line of descent runs back 3 generations to K871390 (1987). 4 ancestors in all. 24 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1992: 1 other ancestor2010: 1 descendant cleared2026: 2 descendants cleared1999: 1 descendant cleared2011: 1 descendant cleared2005: 2 descendants cleared2013: 1 descendant cleared2007: 2 descendants cleared2014: 2 descendants cleared2019: 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 clearedK871390 · Bard Biopty Biopsy System · C.R. Bard, Inc. · 1987K962969 · Medical Device Technologies, Inc.Ultra · Medical Device Technologies, Inc. · 1996K982085 · Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy Instrument · Medical Device Technologies, Inc. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 10 descendants5 generations forward: 5 descendants K982085 · Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy Instrument · Medical Device Technologies, Inc. · 1998K962969 · Medical Device Technologies, Inc.Ultra · Medical Device Technologies, Inc. · 1996K871390 · Bard Biopty Biopsy System · C.R. Bard, Inc. · 19870+5
  1. Root · 3 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
  2. 2 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
  3. 1 generation backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
  4. This deviceK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998
  5. Descendant · cites it directly · 20 of its ownK990839 Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
  6. Descendant · 2 generations on · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
  7. Descendant · 3 generations on · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
  8. Descendant · 4 generations on · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
  9. Descendant · 4 generations on · 4 of its ownK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

1999: 12005: 22007: 22010: 12011: 12013: 12014: 22015: 12018: 12019: 22020: 12021: 22022: 12023: 22024: 12025: 12026: 2
1999high 2 (2005) · low 0 (2000)2026

Most influential descendants

Showing 5 of 24 · See all
  • K990839Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999 · cites it directly20descendants
  • K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L. · 2005 · 2 generations on18descendants
  • K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · 3 generations on12descendants
  • K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · 4 generations on5descendants
  • K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K871390Bard Biopty Biopsy SystemC.R. Bard, Inc.1987—
−2K962969Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc.1996—
−1K982085Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy…Medical Device Technologies, Inc.1998—
0 (this device)K982960Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy InstrumentMedical Device Technologies, Inc.1998—
+1K990839Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc.1999—
+2K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut…Sterylab S.R.L.2005—
+3K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.2013—
+4K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.2014—
+4K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200520
200720
201010
201110
201310
201420
201510
201810
201920
202010
202120
202210
202320
202410
202510
202620
FIG. 1 — Lineage of K982960, 1987–2026Source: 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? (2)

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
*K962969Medical Device Technologies, Inc.Ultra
Summary page 1
…dical Device Technologies DESCRIPTION OF DEVICE: Disposable handle gun for use with disposable biopsy needles. Instrument, Biopsy, No. 78KNW Product Name 510(k) No. K962969 K982085 Tru-Core Tru-Core Semi-Automatic The Tru-Core™ Disposable Automatic Biopsy Instrument is intended for use in obtaining…
Medical Device Technologies, Inc.1996—
*K982085Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy Instrument
Summary page 1
…vice Technologies DESCRIPTION OF DEVICE: Disposable handle gun for use with disposable biopsy needles. Instrument, Biopsy, No. 78KNW Product Name 510(k) No. K962969 K982085 Tru-Core Tru-Core Semi-Automatic The Tru-Core™ Disposable Automatic Biopsy Instrument is intended for use in obtaining multiple…
Medical Device Technologies, Inc.1998—

Also cleared against K962969: 3 other devices →

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K990839Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc.199920
K101832Biopince Ultra Full Core Biopsy InstrumentMedical Device Technologies, Inc.20101
K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…Argon Medical Devices, Inc.20260

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 2, 2024Class IIZ-3192-2024Packaging change controlHoles have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious…
Jul 2, 2010Not classifiedZ-0025-2011OtherMedical Device Technologies, Inc., dba Angiotech, Gaineville, Florida is recalling Tru-Core II Disposable Biopsy Devices due to compromised packaging integrity. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K990839 (Medical Device Technologies, Inc., 1999) has gone furthest, with 20 descendants of its own.
  • 3 other devices also cite its predicate K962969.

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 Tru-Core™ Disposable Automatic Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K962969

3 other devices cite the same predicate.

  • K130282Remington Medical Centrefire 22 Biopsy InstrumentRemington Medical, Inc. · 2013
  • K990839Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
  • K982085Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy InstrumentMedical Device Technologies, Inc. · 1998

More from Medical Device Technologies, Inc.

46 FDA decisions under this applicant name. See the company

  • K101832Biopince Ultra Full Core Biopsy InstrumentMedical Device Technologies, Inc. · 2010
  • K053518Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006
  • K051421Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005
  • K050873Canalizer Hydrophilic Guide WireMedical Device Technologies, Inc. · 2005
  • K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005

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/K982960 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982960: Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982960

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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