510(k) Report

510(k) · Cleared

Cleared

Ultra-Core Biopsy Needles

K921418510(k) TraditionalCleared Jun 19, 199287-day reviewClass I21 CFR 878.4800

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. · DWO Needle, Biopsy, Cardiovascular

Cleared on Jun 19, 1992 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 23 later devices descend from it.

Decided
Jun 19, 1992
Review
87 days
Class
Class I
Product code
DWO
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2017: 1 descendant cleared2005: 1 descendant cleared2023: 3 descendants cleared2013: 1 descendant cleared2007: 2 descendants cleared2025: 2 descendants cleared2014: 2 descendants cleared2019: 2 descendants cleared2018: 1 descendant cleared2024: 1 descendant cleared2021: 2 descendants cleared2015: 1 descendant cleared2026: 1 descendant cleared2022: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK921418 Ultra-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1992
  2. Descendant · cites it directly · 22 of its ownK980226 Manan Pro-Mag Automatic Biopsy SystemMedical Device Technologies, Inc. · 1998 · Recalled
  3. Descendant · 2 generations on · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
  4. Descendant · 3 generations on · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
  5. Descendant · 4 generations on · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
  6. Descendant · 4 generations on · 4 of its ownK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

1998: 12005: 12007: 22013: 12014: 22015: 12017: 12018: 12019: 22020: 12021: 22022: 12023: 32024: 12025: 22026: 1
1998high 3 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 23 · See all
  • K980226Manan Pro-Mag Automatic Biopsy SystemMedical Device Technologies, Inc. · 1998 · cites it directly22descendants
  • 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
0 (this device)K921418Ultra-Core Biopsy NeedlesMedical Device Technologies, Inc.1992—
+1K980226Manan Pro-Mag Automatic Biopsy SystemMedical Device Technologies, Inc.19981
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200510
200720
201310
201420
201510
201710
201810
201920
202010
202120
202210
202330
202410
202520
202610
FIG. 1 — Lineage of K921418, 1992–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K980226Manan Pro-Mag Automatic Biopsy SystemMedical Device Technologies, Inc.199822

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, K980226 (Medical Device Technologies, Inc., 1998) has gone furthest, with 22 descendants of its own.

How does its category compare?

All DWO devices

DWO Needle, Biopsy, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWO

FDA has decided no DWO device since 2007.

Median 510(k) review, days · DWO

Too few DWO 510(k)s in any year since 2007 to give a median.

Recalls per year · DWO

7in 2018

2018: 7
2007high 7 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DWO

6in 2024

2007: 32008: 72009: 92010: 72011: 32012: 92013: 112014: 32015: 82016: 62017: 42018: 92024: 6
2007high 11 (2013) · low 0 (2019)2025

MAUDE reports naming product code DWO, 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
20070—03
20080—07
20090—09
20100—07
20110—03
20120—09
20130—011
20140—03
20150—08
20160—06
20170—04
20180—79
20190—00
20200—00
20210—00
20220—00
20230—00
20240—06
20250—00
20260—0—

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 DWO

The DWO category page

  • K933364Promed Biopsy NeedleVlv Associates, Inc. · 1994
  • K913815Automated Biopsy Device, ModificationHart Enterprises, Inc. · 1991
  • K890925Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 19897 recalls
  • K885145Medsurg Greene NeedleMedsurg Industries, Inc. · 1989
  • K885149Needle Insert for Soft Tissue Biopsy DeviceHart Enterprises, Inc. · 1989

https://510kreport.com/device/K921418 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921418: Ultra-Core Biopsy Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921418

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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