# K120002: I-Style Bone Marrow Aspiration Needle with T-Handle

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hospital Disposables, Inc.
- Decided: Jun 26, 2012 after 175 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: 1 generation back to K061570 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061570: I-Style Bone Marrow Aspiration Needle, Busse Hospital Disposables, Inc. (2006) Summary page 1.
- K110883: J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-IT Marrow Acquisition Cannula, Busse Hospital Disposables (2011) Summary page 1.

## Indications for use
The I-Style Bone Marrow Aspiration Needle with T-Handle is intended for Aspiration of Bone Marrow.

Source page: https://510kreport.com/device/K120002
Methodology: https://510kreport.com/methodology