510(k) · Cleared
ClearedPresto Breast Biopsy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sontina Medical, LLC · KNW Instrument, Biopsy
Cleared on Feb 28, 2014 as substantially equivalent to K120440 (Sontina Medical, LLC, 2012) and 2 other predicates after an 87-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Feb 28, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K003528 (2001). 14 ancestors in all, the oldest K922939 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK003528 Sanarus Core Tissue Biopsy SystemEndocare, Inc. · 2001
- 6 generations backK021137 Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc. · 2002
- 5 generations backK022879 Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002 · Recalled
- 4 generations backK032506 Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003
- 3 generations backK042136 Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004
- 2 generations backK053151 Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005
- 1 generation backK071048 Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007
- This deviceK133702 Presto Breast Biopsy DeviceSontina Medical, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003528 | Sanarus Core Tissue Biopsy System | Endocare, Inc. | 2001 | — |
| −6 | K021137 | Sanarus Centrica Core Tissue Biopsy System | Sanarus Medical, Inc. | 2002 | — |
| −5 | K022879 | Modification to Sanarus Centrica Core Tissue Biopsy | Sanarus Medical, Inc. | 2002 | 1 |
| −4 | K032506 | Sanarus Centrica II Rotational Core Biopsy System | Sanarus Medical, Inc. | 2003 | — |
| −3 | K042136 | Sanarus Cassi Rotational Core Biopsy System | Sanarus Medical, Inc. | 2004 | — |
| −2 | K053151 | Rubicor Magic Breast Biopsy Device | Rubicor Medical, Inc. | 2005 | — |
| −1 | K071048 | Rubicor Magic Breast Biopsy Device, Model 31537 | Rubicor Medical, Inc. | 2007 | — |
| 0 (this device) | K133702 | Presto Breast Biopsy Device | Sontina Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K120440 | Presto Breast Biopsy DeviceSummary page 2…ft in parentheses. _______________Table A.2 Predicate Device Cornparison Table ________ K120440 K708(uio)K003297 Modified Device ____________ (Sontina)… | 2012 |
| * | K071048 | Rubicor Magic Breast Biopsy Device, Model 31537Summary page 1…n Francisco, K 04 CAK104 Rubicor Magic Breast Biopsy Device Enapsl) eia SnFacso K07 1048 Mamnmotome I-land Held 8 Gauge Probe Devicor Medical (Cincinnati, 01-1) K003297 Device Description: The Presto Br… | 2007 |
| * | K003297 | Mammotome Hand Held Probe, Model MHH8Summary page 1…Breast Biopsy Device Enapsl) eia SnFacso K07 1048 Mamnmotome I-land Held 8 Gauge Probe Devicor Medical (Cincinnati, 01-1) K003297 Device Description: The Presto Breast Biopsy Device is a sterile, single-usc percutaneous biopsy device. The working end of the… | 2001 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 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 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.
https://510kreport.com/device/K133702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133702: Presto Breast Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133702
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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