# K010400: Vacuum Assisted Core Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Promex, Inc.
- Decided: Jul 24, 2001 after 162 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K024089: Vacuflash Biopsy System (2003), 4 descendants of its own
- K053151: Rubicor Magic Breast Biopsy Device (2005), 3 descendants of its own
- K071048: Rubicor Magic Breast Biopsy Device, Model 31537 (2007), 1 descendant of its own
- K173316: SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device (2018), 0 descendants of its own
- K133702: Presto Breast Biopsy Device (2014), 0 descendants of its own

## Recalls of this device
- Aug 11, 2010 · Not classified · Z-2285-2010: The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.
- Feb 1, 2010 · Not classified · Z-1160-2010: The product is labeled as ATEC0909-12 but it actually contains 0909-20.
- Sep 22, 2008 · Not classified · Z-0275-2009: The distal tip of the needle may become detached and remain in the patient, requiring surgical removal.
- Dec 15, 2006 · Not classified · Z-0362-2007: The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
- May 25, 2006 · Not classified · Z-1160-06: Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).

Source page: https://510kreport.com/device/K010400
Methodology: https://510kreport.com/methodology