# K904987: Vibronics Auto Core Biopsy Device (Acbd)

- Pathway: 510(k) (Traditional)
- Applicant: Vibronics
- Decided: Feb 11, 1991 after 96 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K111765: Full Core Biopsy System (2011), 4 descendants of its own
- K140137: Safety Biopsy Needle System (2014), 3 descendants of its own
- K160423: Perineologic Access Needle (2016), 2 descendants of its own
- K090611: Revolution Full Core Biopsy (2009), 2 descendants of its own
- K210946: Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles (2021), 1 descendant of its own

## Recalls of this device
- Jul 2, 2024 · Class II · Z-3192-2024: Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, wh
- Dec 2, 2019 · Class II · Z-2427-2020: Incorrect product labeling.

Source page: https://510kreport.com/device/K904987
Methodology: https://510kreport.com/methodology