# K933364: Promed Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Vlv Associates, Inc.
- Decided: Feb 15, 1994 after 221 days
- Product code: DWO (Needle, Biopsy, Cardiovascular)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K140137: Safety Biopsy Needle System (2014), 3 descendants of its own
- K160423: Perineologic Access Needle (2016), 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
- K261196: Promisemed VeriEcto Automatic Biopsy Needles (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K933364
Methodology: https://510kreport.com/methodology