# K930217: Baxter Disposable Intraosseous Infusion Needle

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Feb 28, 1994 after 409 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 3 (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
- Jul 27, 2021 · Class II · Z-0002-2022: Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
- Jun 23, 2021 · Class II · Z-2249-2021: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
- Feb 23, 2017 · Class II · Z-1423-2018: The integrity of the sterile packaging is potentially compromised.

Source page: https://510kreport.com/device/K930217
Methodology: https://510kreport.com/methodology