510(k) · Cleared

Recalled · Class II · 2017

Mammotome revolve Dual Vacuum Assist Biopsy System

K152989510(k) TraditionalCleared Feb 25, 2016135-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

Devicor Medical Products, Inc. · KNW Instrument, Biopsy

Cleared on Feb 25, 2016 as substantially equivalent to K033700 (Ethicon Endo-Surgery, Inc., 2004) and 1 other predicate after a 135-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it. It has been recalled once.

Decided: Feb 25, 2016
Review: 135 days
Class: Class II
Product code: KNW
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K033700 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK033700 Mammotome EX Hand Held SystemEthicon Endo-Surgery, Inc. · 2004 · Recalled
1 generation backK123259 Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) SystemDevicor Medical Products, Inc. · 2012 · Recalled
This deviceK152989 Mammotome revolve Dual Vacuum Assist Biopsy SystemDevicor Medical Products, Inc. · 2016
Descendant · cites it directly · 0 of its ownK202012 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemDevicor Medical Products, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all

K202012Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemDevicor Medical Products, Inc. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K033700	Mammotome EX Hand Held System	Ethicon Endo-Surgery, Inc.	2004	1
−1	K123259	Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) System	Devicor Medical Products, Inc.	2012	1
0 (this device)	K152989	Mammotome revolve Dual Vacuum Assist Biopsy System	Devicor Medical Products, Inc.	2016	—
+1	K202012	Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System	Devicor Medical Products, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K152989, 2004–2020Source: 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? (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
*	K033700	Mammotome EX Hand Held System Summary page 4 …ystem Regulation: 21 CFR 876.1075 Regulatory Class: II Product Codes: KNW Classification Name: Biopsy Instrument Predicate Devices: Mammotome® Biopsy System, K033700 Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System, K123259 === Pag…	Ethicon Endo-Surgery, Inc.	2004	1
*	K123259	Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) System Summary page 4 …dicate Devices: Mammotome® Biopsy System, K033700 Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System, K123259 K152989 Page 2 of 6 510(k) Pr…	Devicor Medical Products, Inc.	2012	1

Also cleared against K033700: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K202012	Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System	Devicor Medical Products, Inc.	2020	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 28, 2017	Class II	Z-1512-2017	Process control	The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
2 of the 2 ancestors have a recall of any class.
Of its descendants, K202012 (Devicor Medical Products, Inc., 2020) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K033700.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. • The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. • The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for…

Read the full statement (227 words)

The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

• The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

• The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) 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 revolve® Dual Vacuum Assisted Biopsy (VAB) 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/K152989 · printed Nov 5, 2026

Cite this page

510(k) Report. “K152989: Mammotome revolve Dual Vacuum Assist Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152989

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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