510(k) · Cleared

Cleared

Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018

K093256510(k) TraditionalCleared Nov 17, 200929-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

Inrad · KNW Instrument, Biopsy

Cleared on Nov 17, 2009 as substantially equivalent to K960064 (Bauer Medical, Inc., 1996) after a 29-day review. Its family tree reaches back 1 generation to 1996.

Decided: Nov 17, 2009
Review: 29 days
Class: Class II
Product code: KNW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K960064 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK960064 Temno Achieve Biopsy NeedleBauer Medical, Inc. · 1996
This deviceK093256 Selectcore Variable Throw Biopsy Device Model 991014, 991514…Inrad · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960064	Temno Achieve Biopsy Needle	Bauer Medical, Inc.	1996	—
0 (this device)	K093256	Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518…	Inrad	2009	—

FIG. 1 — Lineage of K093256, 1996–2009Source: 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
*	K960064	Temno Achieve Biopsy Needle Summary page 1 …Name: Gastroenterology-urology biopsy instrument (21 CFR 876.1075, Product code KNW) Name of Predicate(s) or Legally Marketed Device(s) K960064 - Temno Achieve Biopsy Needle Also known as: > Achieve Programmable Automatic Biopsy System (Cardinal Health)…	Bauer Medical, Inc.	1996	—

Also cleared against K960064: 4 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?

Its one ancestor has no recall.
4 other devices also cite its predicate K960064.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093256 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093256: Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093256

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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