510(k) · Cleared

Recalled · Class II · 2024

Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument

K133948510(k) SpecialCleared Feb 21, 201460-day reviewClass II21 CFR 876.1075Recalls 7

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bard Peripheral Vascular, Inc. · KNW Instrument, Biopsy

Cleared on Feb 21, 2014 as substantially equivalent to K922939 (C.R. Bard, Inc., 1993) after a 60-day review. Its family tree reaches back 1 generation to 1993. 27 later devices descend from it. It has been recalled 7 times.

Decided: Feb 21, 2014
Review: 60 days
Class: Class II
Product code: KNW
Recalls: 7
Predicates: 1

Its longest line of descent runs back 1 generation to K922939 (1993). 27 later devices descend from it, 13 citing it directly.

By dateBy generation

Root · 1 generation backK922939 Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc. · 1993
This deviceK133948 Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R)…Bard Peripheral Vascular, Inc. · 2014
Descendant · cites it directly · 11 of its ownK141552 Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014
Descendant · cites it directly · 5 of its ownK171953 Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · Recalled
Descendant · 2 generations on · 4 of its ownK160316 SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable…M.D.L. S.R.L. · 2016 · Recalled
Descendant · 2 generations on · 2 of its ownK192101 Medone Ultra, MedextraMedax Srl Unipersonale · 2020
Descendant · cites it directly · 2 of its ownK153337 Corvocet Biopsy SystemMerit Medical Systems, Inc. · 2016

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2014high 6 (2022) · low 0 (2015)2026

Most influential descendants

Showing 5 of 27 · See all

K141552Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014 · cites it directly11descendants
K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · cites it directly5descendants
K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L. · 2016 · 2 generations on4descendants
K192101Medone Ultra, MedextraMedax Srl Unipersonale · 2020 · 2 generations on2descendants
K153337Corvocet Biopsy SystemMerit Medical Systems, Inc. · 2016 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922939	Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.	C.R. Bard, Inc.	1993	—
0 (this device)	K133948	Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R)…	Bard Peripheral Vascular, Inc.	2014	—
+1	K141552	Achieve Programmable Auomated Biopsy Systems	Care Fusion	2014	—
+1	K171953	Bard Mission Disposable Core Biopsy Instrument	Bard Peripheral Vascular, Inc.	2017	3
+2	K160316	SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy…	M.D.L. S.R.L.	2016	1
+2	K192101	Medone Ultra, Medextra	Medax Srl Unipersonale	2020	—
+1	K153337	Corvocet Biopsy System	Merit Medical Systems, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2016	2	0
2017	2	0
2018	1	0
2020	4	0
2021	3	0
2022	6	0
2023	1	0
2024	2	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K133948, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K922939	Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. Summary page 1 …21 CFR 676.1075 (Gastroenterology-urology biopsy instrument) 3. Predicate Device: The predicate device is the Bard® Monopty® Disposable Core Biopsy Instrument, K922939, cleared February 16, 1993. 4. Summary of Change: This Special 510(k) provides an updated file to FDA including several changes…	C.R. Bard, Inc.	1993	—

Also cleared against K922939: 2 other devices →

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K141552	Achieve Programmable Auomated Biopsy Systems	Care Fusion	2014	11
K171953	Bard Mission Disposable Core Biopsy Instrument	Bard Peripheral Vascular, Inc.	2017	5
K153337	Corvocet Biopsy System	Merit Medical Systems, Inc.	2016	2
K222865	M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic…	Canyon Medical, Inc.	2023	1
K172344	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	Medax Srl Unipersonale	2017	1
K243296	Disposable Biopsy Needle	Carbon (Shenzhen) Medical Device Co., Ltd.	2025	0
K250032	Marquee™ Disposable Core Biopsy Instrument and Instrument Kit	Bard Peripheral Vascular, Inc.	2025	0
K241793	Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…	Zhejiang Curaway Medical Technology Co., Ltd.	2025	0
K220611	SUREcore Plus Biopsy Instrument	Uro-1, Inc.	2022	0
K214063	Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131…	Guangzhou Shengwei Medical Devices Co., Ltd.	2022	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 30, 2024	Class II	Z-0467-2025	Process change control	Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and…
Aug 10, 2023	Class II	Z-0027-2024	Device Design	Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial…
Jan 14, 2021	Class II	Z-1289-2021	Process control	Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Oct 25, 2019	Class II	Z-0724-2020	Equipment maintenance	During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.
Sep 22, 2017	Class II	Z-0044-2018	Device Design	During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation.
Apr 9, 2015	Class II	Z-1586-2015	Process design	The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
Mar 17, 2015	Class II	Z-1447-2015	Nonconforming Material/Component	Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K141552 (Care Fusion, 2014) has gone furthest, with 11 descendants of its own.
2 other devices also cite its predicate K922939.

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

2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007high 203 (2022) · low 35 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNW

1in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	94	1	766
2008	4	53	7	363
2009	6	35	3	351
2010	3	57	2	162
2011	10	64	5	67
2012	7	94	1	93
2013	3	100	1 (1)	98
2014	8	95	3	193
2015	10	106	0	591
2016	9	127	5	297
2017	8	90	1	760
2018	7	71	0	1,012
2019	5	94	4	4,195
2020	8	92	0	5,120
2021	9	54	3	1,020
2022	8	203	3	535
2023	7	164	2	931
2024	5	114	1	1,283
2025	12	178	0	1,667
2026	7	29	4 (3)	—

What is it indicated for?

The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133948 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133948: Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133948

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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