# K851831: Manan Franseene Needle

- Pathway: 510(k) (Traditional)
- Applicant: Manan Manufacturing Co., Inc.
- Decided: May 14, 1985 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.
9 later devices descend from it; 1 cites it directly.
0 of 10 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
- K980122: Manan Soft Tissue Biopsy Needles (1998), 8 descendants of its own
- K041638: Targetscan Biopsy Kit (2004), 2 descendants of its own
- K162588: Möller Medical Biopsy Needles and Systems (2017), 1 descendant of its own
- K073399: Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide (2007), 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

Source page: https://510kreport.com/device/K851831
Methodology: https://510kreport.com/methodology