510(k) Report

510(k) · Cleared

Cleared

Presto Breast Biopsy Device

K120440510(k) TraditionalCleared May 17, 201294-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

Sontina Medical, LLC · KNW Instrument, Biopsy

Cleared on May 17, 2012 as substantially equivalent to K922939 (C.R. Bard, Inc., 1993) after a 94-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided
May 17, 2012
Review
94 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K922939 (1993). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant clearedK922939 · Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. · C.R. Bard, Inc. · 19931990200020102020
Descendants, by generation 1 generation forward: 1 descendant K922939 · Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. · C.R. Bard, Inc. · 19930
  1. Root · 1 generation backK922939 Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc. · 1993
  2. This deviceK120440 Presto Breast Biopsy DeviceSontina Medical, LLC · 2012
  3. Descendant · cites it directly · 0 of its ownK133702 Presto Breast Biopsy DeviceSontina Medical, LLC · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K133702Presto Breast Biopsy DeviceSontina Medical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922939Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc.1993—
0 (this device)K120440Presto Breast Biopsy DeviceSontina Medical, LLC2012—
+1K133702Presto Breast Biopsy DeviceSontina Medical, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K120440, 1993–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK014101FDA’s K014101 is Rapidone-Oxy Test
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
American Bio Medica Corp.2002—
*K922939Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.
Summary page 1
…________________________________(San Francisco, CA) 1014 Bard Monoptv Bard Biopsy Systems 1K922939 ___________________________(Tempe, AZ) ______ Device Description: The Presto Brea…
C.R. Bard, Inc.1993—

Also cleared against K922939: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K133702Presto Breast Biopsy DeviceSontina Medical, LLC20140

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?

  • Its one ancestor has no recall.
  • Of its descendants, K133702 (Sontina Medical, LLC, 2014) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K922939.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · KNW

12in 2025

2007: 62008: 42009: 62010: 32011: 102012: 72013: 32014: 82015: 102016: 92017: 82018: 72019: 52020: 82021: 92022: 82023: 72024: 52025: 122026 (partial year): 7
2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007: 94 days median2008: 53 days median2009: 35 days median2010: 57 days median2011: 64 days median2012: 94 days median2013: 100 days median2014: 95 days median2015: 106 days median2016: 127 days median2017: 90 days median2018: 71 days median2019: 94 days median2020: 92 days median2021: 54 days median2022: 203 days median2023: 164 days median2024: 114 days median2025: 178 days median2026 (partial year): 29 days median
2007high 203 (2022) · low 35 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNW

1in 2024

2007: 12008: 72009: 32010: 22011: 52012: 12013: 1, 1 Class I2014: 32016: 52017: 12019: 42021: 32022: 32023: 22024: 12026 (partial year): 4, 3 Class I
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

2007: 7662008: 3632009: 3512010: 1622011: 672012: 932013: 982014: 1932015: 5912016: 2972017: 7602018: 1,0122019: 4,1952020: 5,1202021: 1,0202022: 5352023: 9312024: 1,2832025: 1,667
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076941766
20084537363
20096353351
20103572162
20111064567
2012794193
201331001 (1)98
20148953193
2015101060591
201691275297
20178901760
201877101,012
201959444,195
202089205,120
202195431,020
202282033535
202371642931
2024511411,283
20251217801,667
20267294 (3)—

What is it indicated for?

The Presto Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. The Presto Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged…

Read the full statement (133 words)

The Presto Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Presto Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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 removal of 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.

Also cleared against K922939

2 other devices cite the same predicate.

  • K150169Sertera Biopsy DeviceHologic, Inc. · 20153 recalls
  • K133948Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core InstrumentBard Peripheral Vascular, Inc. · 20147 recalls

More from Sontina Medical, LLC

2 FDA decisions under this applicant name. See the company

  • K133702Presto Breast Biopsy DeviceSontina Medical, LLC · 2014

Recent decisions in KNW

The KNW category page

  • K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd. · 2026
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  • K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
  • K260572Marrow MarxmanMedimetrix, LLC · 2026
  • K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026

https://510kreport.com/device/K120440 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120440: Presto Breast 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/K120440

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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