# K222462: Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)

- Pathway: 510(k) (Traditional)
- Applicant: Itp Innovative Tomography Products GmbH
- Decided: Jan 20, 2023 after 158 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
Longest line of descent: 2 generations back to K960064 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K130616: Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-Needles, Biopsybell S.R.L. (2014) Summary page 4.

## Most influential descendants
- K233294: Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM (2024), 0 descendants of its own

## Indications for use
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).

Source page: https://510kreport.com/device/K222462
Methodology: https://510kreport.com/methodology