510(k) Report

510(k) · Cleared

Cleared

Cook Sidearm Core Tissue Biopsy Device

K041544510(k) TraditionalCleared Jul 22, 200443-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

Urological, Inc. · KNW Instrument, Biopsy

Cleared on Jul 22, 2004 as substantially equivalent to K871390 (C.R. Bard, Inc., 1987) and 4 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided
Jul 22, 2004
Review
43 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K863385 (1986). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1987: 1 other ancestor2005: 1 descendant clearedK863385 · (Roth)Spiral Rotating Prostatic Biopsy Needle · Cook Urological, Inc. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K863385 · (Roth)Spiral Rotating Prostatic Biopsy Needle · Cook Urological, Inc. · 19860
  1. Root · 1 generation backK863385 (Roth)Spiral Rotating Prostatic Biopsy NeedleCook Urological, Inc. · 1986
  2. This deviceK041544 Cook Sidearm Core Tissue Biopsy DeviceUrological, Inc. · 2004
  3. Descendant · cites it directly · 0 of its ownK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K863385(Roth)Spiral Rotating Prostatic Biopsy NeedleCook Urological, Inc.1986—
0 (this device)K041544Cook Sidearm Core Tissue Biopsy DeviceUrological, Inc.2004—
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
199210
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K041544, 1986–2005Source: 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? (5)

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
*K871390Bard Biopty Biopsy System
Summary page 1
…Predicate Devices: The Cook® Sidearm Core Tissue Biopsy Device is comparable to existing predicate devices in distribution including the Magnum Biopsy System (K871390) manufactured by C.R. Bard, Incorporated, the EMS Biopsy Instrument (K930083) manufactured by Engineered Medical Systems,…
C.R. Bard, Inc.1987—
*K930083Ems Biopsy Instrument
Summary page 1
…to existing predicate devices in distribution including the Magnum Biopsy System (K871390) manufactured by C.R. Bard, Incorporated, the EMS Biopsy Instrument (K930083) manufactured by Engineered Medical Systems, the High Speed Core Cut Biopsy Device (K905556) manufactured by BIP USA, Incorp…
Engineered Medical Systems1993—
*K905556High Speed Core Cut Biopsy Gun
Summary page 1
…manufactured by C.R. Bard, Incorporated, the EMS Biopsy Instrument (K930083) manufactured by Engineered Medical Systems, the High Speed Core Cut Biopsy Device (K905556) manufactured by BIP USA, Incorporated, the Manan Pro-Mag Automatic Biopsy Device (K914874) manufactured by Manan Medical Pr…
Uni-Quatro Industries Canada, Inc.1991—
*K914874Manan Pro-Mag Automatic Biopsy Device
Summary page 1
…y Engineered Medical Systems, the High Speed Core Cut Biopsy Device (K905556) manufactured by BIP USA, Incorporated, the Manan Pro-Mag Automatic Biopsy Device (K914874) manufactured by Manan Medical Products, Incorporated, and the (Roth) Spiral Rotating Prostatic Biopsy Needle (K863385), man…
Manan Medical Products, Inc.1992—
*K863385(Roth)Spiral Rotating Prostatic Biopsy Needle
Summary page 1
…e Manan Pro-Mag Automatic Biopsy Device (K914874) manufactured by Manan Medical Products, Incorporated, and the (Roth) Spiral Rotating Prostatic Biopsy Needle (K863385), manufactured by Cook Urological, Incorporated. Device Description: The Cook® Sidearm Core Tissue Biopsy Device/Set…
Cook Urological, Inc.1986—

Also cleared against K871390: 3 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050

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 5 ancestors has a recall.
  • Of its descendants, K052435 (Pneumrx, Inc., 2005) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K871390.

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 Cook-® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple cores of tissue sampling from sites including, but not limited to the prostate, kidney, liver, lung, breast, lymph nodes, and different tumors for histological evaluation.

Indications for use as stated in the FDA summary.

Also cleared against K871390

3 other devices cite the same predicate.

  • K963825Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc · 1996
  • K962969Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
  • K962077Bard Biopty-Cut Biopsy Needle/with SpacerC.R. Bard, Inc. · 1996

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/K041544 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041544: Cook Sidearm Core Tissue Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041544

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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