510(k) · Cleared

Recalled · Class II · 2025

Sertera Biopsy Device

K150169510(k) TraditionalCleared Aug 14, 2015200-day reviewClass II21 CFR 876.1075Recalls 3

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

Cleared on Aug 14, 2015 as substantially equivalent to K960064 (Bauer Medical, Inc., 1996) and 1 other predicate after a 200-day review. Its family tree reaches back 1 generation to 1993. It has been recalled 3 times.

Decided: Aug 14, 2015
Review: 200 days
Class: Class II
Product code: KNW
Recalls: 3
Predicates: 2

Its longest line of descent runs back 1 generation to K922939 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK922939 Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc. · 1993
This deviceK150169 Sertera Biopsy DeviceHologic, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922939	Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.	C.R. Bard, Inc.	1993	—
0 (this device)	K150169	Sertera Biopsy Device	Hologic, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K150169, 1993–2015Source: 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
*	K960064	Temno Achieve Biopsy Needle Summary page 4 …ICES 6.8.1 Tradename: Achieve Programmable Automatic Biopsy Needle Submitter / 510(k) Holder: (Bauer Medical) CareFusion (Cardinal Health) 510(k) #: K960064 Classification code: KNW and Regulation: 21.CFR.876.1075. 6.8.2 Tradename: Monopty Disposable Core Biopsy Instrument…	Bauer Medical, Inc.	1996	—
*	K922939	Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. Summary page 4 …and Regulation: 21.CFR.876.1075. 6.8.2 Tradename: Monopty Disposable Core Biopsy Instrument Submitter / 510(k) Holder: C.R. Bard, Inc. 510(k) #: K922939 Classification code: KNW and Regulation: 21.CFR.876.1075. 6.9 DEVICE DESCRIPTION The Hologic Sertera Biopsy Device is a s…	C.R. Bard, Inc.	1993	—

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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 15, 2025	Class II	Z-1170-2025	Process control	Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
May 2, 2023	Class II	Z-2035-2023	Device Design	The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Aug 22, 2016	Class II	Z-2869-2016	Labeling Change Control	Incorrect label on the Sertera Biopsy Kit

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a 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. 2015, 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 Sertera Biopsy Device is intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast. When used for breast biopsy, the product is for diagnosis only. It is not intended for use in bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150169 · printed Nov 5, 2026

Cite this page

510(k) Report. “K150169: Sertera Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150169

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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