# K930083: Ems Biopsy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Apr 21, 1993 after 104 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.
2 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K041544: Cook Sidearm Core Tissue Biopsy Device (2004), 1 descendant of its own
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K930083
Methodology: https://510kreport.com/methodology