510(k) · Cleared

Recalled · Class II · 2015

Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, with/Hilitier 18GAX10CM , W/Hiliter 18GAX15CM

K112945510(k) SpecialCleared Nov 3, 201130-day reviewClass II21 CFR 876.1075Recalls 1

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

Inrad, Inc. · KNW Instrument, Biopsy

Cleared on Nov 3, 2011 as substantially equivalent to K090611 (Inrad, 2009) after a 30-day review. Its family tree reaches back 2 generations to 1991. It has been recalled once.

Decided: Nov 3, 2011
Review: 30 days
Class: Class II
Product code: KNW
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K904987 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK904987 Vibronics Auto Core Biopsy Device (Acbd)Vibronics · 1991 · Recalled
1 generation backK090611 Revolution Full Core BiopsyInrad · 2009
This deviceK112945 Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20…Inrad, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K904987	Vibronics Auto Core Biopsy Device (Acbd)	Vibronics	1991	2
−1	K090611	Revolution Full Core Biopsy	Inrad	2009	—
0 (this device)	K112945	Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, with/Hilitier…	Inrad, Inc.	2011	—

FIG. 1 — Lineage of K112945, 1991–2011Source: 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
*	K090611	Revolution Full Core Biopsy Summary page 1 …: Gastroenterology-urology biopsy instrument (21 CFR 876.1075, Product code KNW) Name of Predicate(s) or Legally Marketed Device(s) K090611- Revolution® Full Core Biopsy Device Section 5 - 1 INRAD, INC.…	Inrad	2009	—

Also cleared against K090611: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 24, 2015	Class II	Z-1671-2015	Device Design	Potential for the device cannula to overthrow past the intended length.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 18.3 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K090611.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112945 · printed Nov 4, 2026

Cite this page

510(k) Report. “K112945: Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, with/Hilitier 18GAX10CM , W/Hiliter 18GAX15CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112945

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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