510(k) Report

510(k) · Cleared

Cleared

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem

K161409510(k) TraditionalCleared Aug 2, 201674-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

Mermaid Medical A/S · KNW Instrument, Biopsy

Cleared on Aug 2, 2016 as substantially equivalent to K974814 (Medical Device Technologies, Inc., 1998) after a 74-day review. Its family tree reaches back 2 generations to 1995. 6 later devices descend from it.

Decided
Aug 2, 2016
Review
74 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K950732 (1995). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2025: 2 descendants cleared2023: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant clearedK950732 · Manan Super-Core Biopsy Needle · Manan Medical Products, Inc. · 1995K974814 · Manan (TM) Super-Core Biopsy Needles · Medical Device Technologies, Inc. · 1998 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 1 descendant K974814 · Manan (TM) Super-Core Biopsy Needles · Medical Device Technologies, Inc. · 1998 · recalledK950732 · Manan Super-Core Biopsy Needle · Manan Medical Products, Inc. · 19950
  1. Root · 2 generations backK950732 Manan Super-Core Biopsy NeedleManan Medical Products, Inc. · 1995
  2. 1 generation backK974814 Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1998 · Recalled
  3. This deviceK161409 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial…Mermaid Medical A/S · 2016
  4. Descendant · cites it directly · 5 of its ownK171953 Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · Recalled
  5. Descendant · 2 generations on · 1 of its ownK222865 M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy…Canyon Medical, Inc. · 2023
  6. Descendant · 2 generations on · 0 of its ownK250032 Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc. · 2025
  7. Descendant · 2 generations on · 0 of its ownK241793 Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy…Zhejiang Curaway Medical Technology Co., Ltd. · 2025
  8. Descendant · 3 generations on · 0 of its ownK233031 M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy…Canyon Medical, Inc. · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 12020: 12023: 12024: 12025: 2
2017high 2 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 6 · See all
  • K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · cites it directly5descendants
  • K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic…Canyon Medical, Inc. · 2023 · 2 generations on1descendant
  • K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc. · 2025 · 2 generations on0descendants
  • K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…Zhejiang Curaway Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
  • K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic…Canyon Medical, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K950732Manan Super-Core Biopsy NeedleManan Medical Products, Inc.1995—
−1K974814Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc.19981
0 (this device)K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle…Mermaid Medical A/S2016—
+1K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc.20173
+2K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore…Canyon Medical, Inc.2023—
+2K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc.2025—
+2K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/…Zhejiang Curaway Medical Technology Co., Ltd.2025—
+3K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore…Canyon Medical, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202010
202310
202410
202520
FIG. 1 — Lineage of K161409, 1995–2025Source: 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? (1)

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
*K974814Manan (TM) Super-Core Biopsy Needles
Summary page 4
…KNW Classification Panel: Gastroenterology/Urology Regulatory Class: Class II Predicate Device: SuperCore™ Biopsy Instrument (K974814) III. Device Description The M-Biopsy™ Semi-Automatic Biopsy Instrument is a disposable lightweight spring loaded…
Medical Device Technologies, Inc.19981

Also cleared against K974814: 4 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc.20175

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?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 18.6 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K171953 (Bard Peripheral Vascular, Inc., 2017) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K974814.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

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?

(N301) Disposable Semi-Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy

samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas,

for microscopic examination.

(N302) Coaxial Introducer Needle is used as a guiding needle for (N301)

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 K974814

4 other devices cite the same predicate.

  • K213232NovaCore Semi-Automatic Biopsy InstrumentArgon Medical Devices · 2022
  • K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005
  • K052802Manan Bio-Cut Soft Tissue Biopsy NeedleManan Medical Products, Inc. · 2005
  • K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue BiopsySterylab S.R.L. · 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/K161409 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161409: M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161409

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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