510(k) · Cleared

Cleared

M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle

K233031510(k) TraditionalCleared Jan 17, 2024114-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

Canyon Medical, Inc. · KNW Instrument, Biopsy

Cleared on Jan 17, 2024 as substantially equivalent to K222865 (Canyon Medical, Inc., 2023) after a 114-day review. Its family tree reaches back 5 generations to 1995.

Decided: Jan 17, 2024
Review: 114 days
Class: Class II
Product code: KNW
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K950732 (1995). 7 ancestors in all, the oldest K922939 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK950732 Manan Super-Core Biopsy NeedleManan Medical Products, Inc. · 1995
4 generations backK974814 Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1998 · Recalled
3 generations backK161409 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial…Mermaid Medical A/S · 2016
2 generations backK171953 Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · Recalled
1 generation backK222865 M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy…Canyon Medical, Inc. · 2023
This deviceK233031 M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy…Canyon Medical, Inc. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K950732	Manan Super-Core Biopsy Needle	Manan Medical Products, Inc.	1995	—
−4	K974814	Manan (TM) Super-Core Biopsy Needles	Medical Device Technologies, Inc.	1998	1
−3	K161409	M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle…	Mermaid Medical A/S	2016	—
−2	K171953	Bard Mission Disposable Core Biopsy Instrument	Bard Peripheral Vascular, Inc.	2017	3
−1	K222865	M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore…	Canyon Medical, Inc.	2023	—
0 (this device)	K233031	M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore…	Canyon Medical, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
2014	1	0

FIG. 1 — Lineage of K233031, 1995–2024Source: 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
*	K222865	M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic… Summary page 4 …: KNW Review Panel: Gastroenterology/Urology 5. Predicate Device(s) Information Subject device Predicate device - K222865 Automatic Disposable Biopsy Needle Automatic Disposable Biopsy Needle Semi-automatic Disposable Biopsy Needle…	Canyon Medical, Inc.	2023	—
†	K133948	Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable…	Bard Peripheral Vascular, Inc.	2014	7
†	K171953	Bard Mission Disposable Core Biopsy Instrument	Bard Peripheral Vascular, Inc.	2017	3

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 29 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
3 of the 7 ancestors have a recall of any class.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?

Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K233031 · printed Nov 6, 2026

Cite this page

510(k) Report. “K233031: M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233031

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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