# K840033: Hypodermic Needles & Stylets

- Pathway: 510(k) (Traditional)
- Applicant: Microvasive
- Decided: Apr 5, 1984 after 91 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 2 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Aug 9, 2004 · Not classified · Z-1445-04: Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
- Aug 9, 2004 · Not classified · Z-1444-04: Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.

Source page: https://510kreport.com/device/K840033
Methodology: https://510kreport.com/methodology