# K120440: Presto Breast Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Sontina Medical, LLC
- Decided: May 17, 2012 after 94 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922939 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922939: Bard Monopty Disposable Core Biopsy Isnt. W/ Cent., C.R. Bard, Inc. (1993) Summary page 1.

## Cited in the summary but kept off the family tree
- K014101: Rapidone-Oxy Test, American Bio Medica Corp. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133702: Presto Breast Biopsy Device (2014), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K120440
Methodology: https://510kreport.com/methodology