# K061570: I-Style Bone Marrow Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hospital Disposables, Inc.
- Decided: Jul 3, 2006 after 27 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.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Manan Bone Marrow Aspiration Needle: named in the summary without a submission number

## Most influential descendants
- K121181: Swannshidi Bone Marrow Aspiration Needle (2012), 6 descendants of its own
- K140991: Ranfac Aspiration Needle with Adjustable Guide (2014), 5 descendants of its own
- K150563: Marrow Cellution Bone Marrow Aspiration Needle (2015), 4 descendants of its own
- K223612: Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) (2023), 1 descendant of its own
- K202287: Ran-Flex-B Bone Marrow Aspiration Needle (2020), 1 descendant of its own

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

Source page: https://510kreport.com/device/K061570
Methodology: https://510kreport.com/methodology