# K052843: Busse Hospital Disposables Needle Stick Block/Cube

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hospital Disposables, Inc.
- Decided: Apr 17, 2006 after 192 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) SharpsAway Disposal Cup: named in the summary without a submission number

## Indications for use
The Needle Stick Block is a single needle holder to be used after the needle is removed from the patient and until it can be properly disposed, therefore, aiding in the prevention of needle stick injuries

Source page: https://510kreport.com/device/K052843
Methodology: https://510kreport.com/methodology