# K994272: Automated Core Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Promex, Inc.
- Decided: Jan 7, 2000 after 18 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.
5 later devices descend from it; 3 cite 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111529: Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core Tissue Biopsy Needle Model MCN- (2011), 2 descendants of its own
- K162588: Möller Medical Biopsy Needles and Systems (2017), 1 descendant of its own
- K242128: Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (2025), 0 descendants of its own
- K093399: Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520 (2009), 0 descendants of its own
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

## Indications for use
To obtain percutaneous core biopsy samples fram soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast and lymph nodes. When used for breast biopsy, the product is for diagnosis only.

Source page: https://510kreport.com/device/K994272
Methodology: https://510kreport.com/methodology