510(k) · Cleared

Cleared

TeesuVac Breast Biopsy Device Mark 1

K212079510(k) TraditionalCleared Feb 2, 2022215-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

Teesuvac Aps · KNW Instrument, Biopsy

Cleared on Feb 2, 2022 as substantially equivalent to K133948 (Bard Peripheral Vascular, Inc., 2014) after a 215-day review. Its family tree reaches back 2 generations to 1993.

Decided: Feb 2, 2022
Review: 215 days
Class: Class II
Product code: KNW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K922939 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK922939 Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc. · 1993
1 generation backK133948 Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R)…Bard Peripheral Vascular, Inc. · 2014 · Recalled
This deviceK212079 TeesuVac Breast Biopsy Device Mark 1Teesuvac Aps · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K922939	Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.	C.R. Bard, Inc.	1993	—
−1	K133948	Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R)…	Bard Peripheral Vascular, Inc.	2014	7
0 (this device)	K212079	TeesuVac Breast Biopsy Device Mark 1	Teesuvac Aps	2022	—

FIG. 1 — Lineage of K212079, 1993–2022Source: 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
*	K133948	Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable… Summary page 5 …gy biopsy instrument Product Code: KNW Predicate Device Predicate #1: Trade/Proprietary Name: Bard Max-Core Disposable Core Biopsy Instrument Premarket Notification: k133948 Manufacturer: Bard Peripheral Vascular, Inc TeesuVac Breast Biopsy Device Mark 1 is a sterile, tetherless vacuum-assisted handh…	Bard Peripheral Vascular, Inc.	2014	7

Also cleared against K133948: 12 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 21.0 years on median.
1 of the 2 ancestors has a recall of any class.
12 other devices also cite its predicate K133948.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 TeesuVac Breast Biopsy Device Mark 1 is indicated to obtain percutaneous core biopsy specimens from soft tissue, and tumors of the breast. This product is intended for diagnostic use only, NOT therapeutic therapy. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance.…

Read the full statement (116 words)

The TeesuVac Breast Biopsy Device Mark 1 is indicated to obtain percutaneous core biopsy specimens from soft tissue,

and tumors of the breast. This product is intended for diagnostic use only, NOT therapeutic therapy. The instrument is

intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent

of removing the 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K212079 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212079: TeesuVac Breast Biopsy Device Mark 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212079

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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