510(k) Report

510(k) · Cleared

Cleared

Medical Device Technologies, Inc.Ultra

K962969510(k) TraditionalCleared Dec 6, 1996128-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

Medical Device Technologies, Inc. · KNW Instrument, Biopsy

Cleared on Dec 6, 1996 as substantially equivalent to K914874 (Manan Medical Products, Inc., 1992) and 1 other predicate after a 128-day review. Its family tree reaches back 1 generation to 1987. 27 later devices descend from it.

Decided
Dec 6, 1996
Review
128 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K871390 (1987). 2 ancestors in all. 27 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1992: 1 other ancestor1998: 2 descendants cleared2013: 2 descendants cleared1999: 1 descendant cleared2010: 1 descendant cleared2026: 2 descendants cleared2005: 2 descendants cleared2007: 2 descendants cleared2011: 1 descendant 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. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 10 descendants5 generations forward: 5 descendants K871390 · Bard Biopty Biopsy System · C.R. Bard, Inc. · 19870+5
  1. Root · 1 generation backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
  2. This deviceK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
  3. Descendant · cites it directly · 25 of its ownK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
  4. Descendant · cites it directly · 24 of its ownK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
  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

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

1998: 21999: 12005: 22007: 22010: 12011: 12013: 22014: 22015: 12018: 12019: 22020: 12021: 22022: 12023: 22024: 12025: 12026: 2
1998high 2 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 27 · See all
  • K982085Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy InstrumentMedical Device Technologies, Inc. · 1998 · cites it directly25descendants
  • K982960Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy InstrumentMedical Device Technologies, Inc. · 1998 · cites it directly24descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K871390Bard Biopty Biopsy SystemC.R. Bard, Inc.1987—
0 (this device)K962969Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc.1996—
+1K982085Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy…Medical Device Technologies, Inc.1998—
+1K982960Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy InstrumentMedical Device Technologies, Inc.19982
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
200520
200720
201010
201110
201320
201420
201510
201810
201920
202010
202120
202210
202320
202410
202510
202620
FIG. 1 — Lineage of K962969, 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), 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
*K914874Manan Pro-Mag Automatic Biopsy Device
Summary page 1
…ble biopsy needles. CLASSIFICATION NAME: Instrument, Biopsy, No. 78KNW SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) No. Manan Medical Products Pro Mag 2.2 K914874 C.R. Bard Biopty Biopsy System K871390 DESCRIPTION OF DEVICE: Our company is presently authorized by the Food and Drug Administ…
Manan Medical Products, Inc.1992—
*K871390Bard Biopty Biopsy System
Summary page 1
…E: Instrument, Biopsy, No. 78KNW SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) No. Manan Medical Products Pro Mag 2.2 K914874 C.R. Bard Biopty Biopsy System K871390 DESCRIPTION OF DEVICE: Our company is presently authorized by the Food and Drug Administration to manufacture disposable soft t…
C.R. Bard, Inc.1987—

Also cleared against K914874: 4 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K982085Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy InstrumentMedical Device Technologies, Inc.199825
K982960Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy InstrumentMedical Device Technologies, Inc.199824
K990839Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc.199920
K130282Remington Medical Centrefire 22 Biopsy InstrumentRemington Medical, Inc.20130

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K982085 (Medical Device Technologies, Inc., 1998) has gone furthest, with 25 descendants of its own.
  • 4 other devices also cite its predicate K914874.

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 Ultra™ Biopsy Device is used to obtain 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 K914874

4 other devices cite the same predicate.

  • K041544Cook Sidearm Core Tissue Biopsy DeviceUrological, Inc. · 2004
  • K982085Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy InstrumentMedical Device Technologies, Inc. · 1998
  • K981477Medical Biopsy Automatic Cutting NeedleMedical Biopsy, Inc. · 1998
  • K980226Manan Pro-Mag Automatic Biopsy SystemMedical Device Technologies, Inc. · 19981 recall

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/K962969 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962969: Medical Device Technologies, Inc.Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962969

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