510(k) Report

510(k) · Cleared

Cleared

ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial

K252795510(k) TraditionalCleared Feb 23, 2026174-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

Argon Medical Devices, Inc. · KNW Instrument, Biopsy

Cleared on Feb 23, 2026 as substantially equivalent to K982960 (Medical Device Technologies, Inc., 1998) after a 174-day review. Its family tree reaches back 4 generations to 1987.

Decided
Feb 23, 2026
Review
174 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K871390 (1987). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 1 other ancestorReference device: K133948 · Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument · Bard Peripheral Vascular, Inc. · 2014 · recalledReference device: K980004 · Manan General Purpose Introducer Needle · Medical Device Technologies, Inc. · 1998K871390 · Bard Biopty Biopsy System · C.R. Bard, Inc. · 1987K962969 · Medical Device Technologies, Inc.Ultra · Medical Device Technologies, Inc. · 1996×2: 2 generations cleared close together, K982085 (1998), K982960 (1998) 1990200020102020
Other ancestors, by generation 3 generations back: 1 other ancestor K982960 · Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument · Medical Device Technologies, Inc. · 1998 · recalledK982085 · 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
  1. Root · 4 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
  2. 3 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
  3. 2 generations backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
  4. 1 generation backK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
  5. This deviceK252795 ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore…Argon Medical Devices, Inc. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K871390Bard Biopty Biopsy SystemC.R. Bard, Inc.1987—
−3K962969Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc.1996—
−2K982085Medical 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
0 (this device)K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy…Argon Medical Devices, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
FIG. 1 — Lineage of K252795, 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? (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
*K982960Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument
Summary page 6
…y Instrument Classification Name: Gastroenterology-urology biopsy instrument Predicate Device K982960 Premarket Notification: Manufacturer: Medical Device Technologi…
Medical Device Technologies, Inc.19982
†K133948Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable…Bard Peripheral Vascular, Inc.20147
†K980004Manan General Purpose Introducer NeedleMedical Device Technologies, Inc.1998—

Also cleared against K982960: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 39 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K982960.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?

The ZeniCoreTM Automatic Biopsy Instrument and optional Co-Axial Introducer Needle is a single-use device indicated for obtaining core samples of soft tissue masses via percutaneous needle biopsy. It is not intended for use in bone.

Indications for use as stated in the FDA summary.

Also cleared against K982960

2 other devices cite the same predicate.

  • K101832Biopince Ultra Full Core Biopsy InstrumentMedical Device Technologies, Inc. · 2010
  • K990839Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999

More from Argon Medical Devices, Inc.

20 FDA decisions under this applicant name. See the company

  • K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration…Argon Medical Devices, Inc. · 2026
  • K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc. · 2026
  • K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc. · 2025
  • K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. · 2024
  • K241145TLAB® Transvenous Liver Biopsy System (TF-18C)Argon Medical Devices, Inc. · 2024

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/K252795 · printed Nov 5, 2026

Cite this page

510(k) Report. “K252795: ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252795

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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