510(k) · Cleared

Cleared

Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System

K030472510(k) TraditionalCleared Oct 9, 2003239-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

Ethicon Endo-Surgery, Inc. · KNW Instrument, Biopsy

Cleared on Oct 9, 2003 as substantially equivalent to K992813 (Ethicon Endo-Surgery, Inc., 1999) and 1 other predicate after a 239-day review. Its family tree reaches back 1 generation to 1999. 7 later devices descend from it.

Decided: Oct 9, 2003
Review: 239 days
Class: Class II
Product code: KNW
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K991980 (1999). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK991980 Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH…Ethicon Endo-Surgery, Inc. · 1999
This deviceK030472 Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003
Descendant · cites it directly · 5 of its ownK093512 Encor Breast Biopsy SystemSenorx, Inc. · 2009
Descendant · 2 generations on · 3 of its ownK111100 Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011
Descendant · 2 generations on · 2 of its ownK233220 EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast…Senorx, Inc. · 2023
Descendant · 3 generations on · 1 of its ownK252681 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025 · Recalled
Descendant · 4 generations on · 0 of its ownK262571 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all

K093512Encor Breast Biopsy SystemSenorx, Inc. · 2009 · cites it directly5descendants
K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011 · 2 generations on3descendants
K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc. · 2023 · 2 generations on2descendants
K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025 · 3 generations on1descendant
K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991980	Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster…	Ethicon Endo-Surgery, Inc.	1999	—
0 (this device)	K030472	Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System	Ethicon Endo-Surgery, Inc.	2003	—
+1	K093512	Encor Breast Biopsy System	Senorx, Inc.	2009	—
+2	K111100	Encor Enspire Breast Biopsy System	C.R. Bard, Inc.	2011	—
+2	K233220	EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…	Senorx, Inc.	2023	—
+3	K252681	EnCor EnCompass™ Breast Biopsy and Tissue Removal System	Bard Peripheral Vascular, Inc.	2025	1
+4	K262571	EnCor EnCompass™ Breast Biopsy and Tissue Removal System	Bard Peripheral Vascular, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	1	0
2011	1	0
2018	1	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K030472, 1999–2026Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K992813	11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe, Ultrasound… Summary page 1 …03 Device Name Trade Name: Mammotome Biopsy System Classification Name: Biopsy Instwmnt Predicate Device Mammotome Biopsy System cleared under K992813 on 11/18/99 and Ii4ammtom Hand Held System c l m d unda K991980 on 8/17/99. Device Description The Mammntome Bi…	Ethicon Endo-Surgery, Inc.	1999	—
*	K991980	Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and… Summary page 1 …ssification Name: Biopsy Instwmnt Predicate Device Mammotome Biopsy System cleared under K992813 on 11/18/99 and Ii4ammtom Hand Held System c l m d unda K991980 on 8/17/99. Device Description The Mammntome Biopsy System is a mechanical breast biopay device used in hcisbnal breast biopsy.…	Ethicon Endo-Surgery, Inc.	1999	—

Also cleared against K992813: 1 other device →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K093512	Encor Breast Biopsy System	Senorx, Inc.	2009	5
K052246	Modification to EN-Bloc Biopsy System	Neothermia Corporation	2005	0

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 2 ancestors has a recall.
Of its descendants, K093512 (Senorx, Inc., 2009) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K992813.

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

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 Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot…

Read the full statement (205 words)

The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030472: Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030472

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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