# K974575: Daum Aspirationbiopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Daum Corp.
- Decided: Mar 6, 1998 after 88 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own
- K013108: Biosuc (2002), 0 descendants of its own
- K013109: Sonopsy (2002), 0 descendants of its own

## Indications for use
The Daum AspirationBiopsy Needle is intended for use in precutaneous or open surgical biopsies, including, but not limited to biopsy of breast, kidney, liver, lymph nodes, and prostate. The Daum AspirationBiopsy Needle is also a low-artifact-instrument designed to be used in the MRI for the above purposes.

Source page: https://510kreport.com/device/K974575
Methodology: https://510kreport.com/methodology