510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-Needles

K130616510(k) TraditionalCleared Feb 7, 2014337-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

Biopsybell S.R.L. · KNW Instrument, Biopsy

Cleared on Feb 7, 2014 as substantially equivalent to K011104 (Biopsybell S.A.S., 2001) and 2 other predicates after a 337-day review. Its family tree reaches back 1 generation to 1996. 7 later devices descend from it. It has been recalled 2 times.

Decided
Feb 7, 2014
Review
337 days
Class
Class II
Product code
KNW
Recalls
2
Predicates
3

Its longest line of descent runs back 1 generation to K960064 (1996). 3 ancestors in all. 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2021: 1 descendant cleared2017: 2 descendants cleared2023: 1 descendant cleared2025: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant clearedK960064 · Temno Achieve Biopsy Needle · Bauer Medical, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants K960064 · Temno Achieve Biopsy Needle · Bauer Medical, Inc. · 19960
  1. Root · 1 generation backK960064 Temno Achieve Biopsy NeedleBauer Medical, Inc. · 1996
  2. This deviceK130616 Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles…Biopsybell S.R.L. · 2014
  3. Descendant · cites it directly · 1 of its ownK222462 Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic…Itp Innovative Tomography Products GmbH · 2023
  4. Descendant · cites it directly · 1 of its ownK172344 Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale · 2017
  5. Descendant · cites it directly · 1 of its ownK162588 Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017
  6. Descendant · 2 generations on · 0 of its ownK242128 Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy…Xaga Surgical · 2025
  7. Descendant · 2 generations on · 0 of its ownK233294 Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbH · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2017: 22020: 12021: 12023: 12024: 12025: 1
2017high 2 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 7 · See all
  • K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15)…Itp Innovative Tomography Products GmbH · 2023 · cites it directly1descendant
  • K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale · 2017 · cites it directly1descendant
  • K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017 · cites it directly1descendant
  • K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical · 2025 · 2 generations on0descendants
  • K233294Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960064Temno Achieve Biopsy NeedleBauer Medical, Inc.1996—
0 (this device)K130616Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles…Biopsybell S.R.L.2014—
+1K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM…Itp Innovative Tomography Products GmbH2023—
+1K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale2017—
+1K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH2017—
+2K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and…Xaga Surgical2025—
+2K233294Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbH2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
202010
202110
202310
202410
202510
FIG. 1 — Lineage of K130616, 1996–2025Source: 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? (3)

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
*K011104Osteobell
Summary page 12
…ntial Equivalence: We claim that our Needles for bone-marrow biopsy are substantially equivalent to: - OSTEOBELL Bone Marrow Needle by Biopsybell sas., 51 0(k): K01 1104; And the devices are identical in the material, principles and basic function. They have the same intended use and differ only i…
Biopsybell S.A.S.2001—
*K010735Speedybell
Summary page 13
…tial Equivalence: We claim that our Semiautomatic guillotine needles for soft-tissue biopsy are substantially equivalent to: - SPEEDYBELL by Biopsybell sas., 510(k): K010735; The devices are identical in the material, principles and basic function. They have the same intended use and differ only in op…
Biopsybell S.A.S.2001—
*K960064Temno Achieve Biopsy Needle
Summary page 14
…oft-tissue biopsy are substantially equivalent to: - TEMNO ACHIEVE@ BIOPSY NEEDLE by Bauer Medical, Inc., distributed by CareFusion Corporation, 510(k): K960064 The devices are identical in the material, principles and basic function. They have the same intended use and differ only in opt…
Bauer Medical, Inc.1996—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15)…Itp Innovative Tomography Products GmbH20231
K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale20171
K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171
K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 25, 2021Class IIZ-1700-2021Vendor change controlProducts distributed as sterile may not have been adequately sterilized
Mar 22, 2021Class IIZ-1634-2021Vendor change controlProducts labeled as sterile were distributed, but may not have been sterilized.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K222462 (Itp Innovative Tomography Products GmbH, 2023) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?

- OSThOBELL 'T': Needle for bone-marrow biopsy - ORION: Needle for bone-marrow biopsy - ILIAC-MARROW: Needle for bone-marrow biopsy - OBSTERN: Needle for bone-marrow biopsy - STERLNOBELL: Needle for bone-marrow biopsy - TOTALLY REMOVE; Needle for bone-marrow biopsy - UNLUX SYSTEM: Needle for bone-marrow biopsy - OSTEOBELL EXPLANT: Needle for bone-marrow explant - ORION EXPLANT: Needle for bone-marrow explant - ILIAC-MARROW EXPLANT: Needle for bone-marrow…

Read the full statement (168 words)

- OSThOBELL 'T': Needle for bone-marrow biopsy

- ORION: Needle for bone-marrow biopsy

- ILIAC-MARROW: Needle for bone-marrow biopsy

- OBSTERN: Needle for bone-marrow biopsy

- STERLNOBELL: Needle for bone-marrow biopsy

- TOTALLY REMOVE; Needle for bone-marrow biopsy

- UNLUX SYSTEM: Needle for bone-marrow biopsy

- OSTEOBELL EXPLANT: Needle for bone-marrow explant

- ORION EXPLANT: Needle for bone-marrow explant

- ILIAC-MARROW EXPLANT: Needle for bone-marrow explant

- OBSTERN EXPLANT: Needle for bone-marrow explant

- STERNOBELL EXPLANT: Needle for bone-marrow explant

- SPEEDYBELL: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS BREAST, KIDNEY, LIVER, PROSTATE)

- SPEEDYBELL & INTRODUTTORE: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS BREAST, KIDNEY, LIVER, PROSTATE)

- SPEEDYBELL DOPPIA CORSA: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS BREAST, KIDNEY, LIVER, PROSTATE)

- SPEEDYBELL DOPPIA CORSA & INTRODUTTORE: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS BREAST, KIDNEY, LIVER, PROSTATE)

- ESTER: AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS LIVER)

- ESTER & INTRODUTTORE: AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS LIVER)

Indications for use as stated in the FDA summary.

More from Biopsybell S.R.L.

4 FDA decisions under this applicant name. See the company

  • K231340Renova Spine Balloon CatheterBiopsybell S.R.L. · 2023
  • K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm…Biopsybell S.R.L. · 2021
  • K180315DiskomBiopsybell S.R.L. · 2018

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/K130616 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130616: Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-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/K130616

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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