510(k) · Cleared

Cleared

Percutaneous Breast Biopsy (PBB)

K972328510(k) TraditionalCleared Jul 7, 1998379-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

Urothealth System, Inc. · KNW Instrument, Biopsy

Cleared on Jul 7, 1998 after a 379-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Jul 7, 1998
Review: 379 days
Class: Class II
Product code: KNW
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK972328 Percutaneous Breast Biopsy (PBB)Urothealth System, Inc. · 1998
Descendant · cites it directly · 1 of its ownK011575 22MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001
Descendant · 2 generations on · 0 of its ownK040087 RabbitScion International, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all

K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001 · cites it directly1descendant
K040087RabbitScion International, Inc. · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K972328	Percutaneous Breast Biopsy (PBB)	Urothealth System, Inc.	1998	—
+1	K011575	22MM Siteselect Breast Biopsy Device Model SSD022	Imagyn Surgical	2001	—
+2	K040087	Rabbit	Scion International, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2004	1	0

FIG. 1 — Lineage of K972328, 1998–2004Source: 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? (6)

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	Recalls
*	—	United States Surgical Corporation (USSC) ABBI device Named without a submission number	—
*	—	C.R. Bard device Named without a submission number	—
*	—	Biopsys Medical device Named without a submission number	—
*	—	USSC instrument holding devices Named without a submission number	—
*	—	Biopsys instrument holding devices Named without a submission number	—
*	—	C.R. Bard Magnum devices Named without a submission number	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K011575	22MM Siteselect Breast Biopsy Device Model SSD022	Imagyn Surgical	2001	1

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?

Of its descendants, K011575 (Imagyn Surgical, 2001) has gone furthest, with 1 descendant of its own.

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?

Diagnostic device used to obtain localized biopsies within breast tissue. Device is for diagnostics purpose only, it is not for therapeutic use. To be used with Percutaneous Breast Biopsy Instrument Accessories (Instrument Holder, Needle Holder, and Stop), which are attached to a stereotactic table and used in conjunction with stereotactic mammographic imaging systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972328 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972328: Percutaneous Breast Biopsy (PBB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972328

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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