# K873957: Non-Coring Huber Type Needles

- Pathway: 510(k) (Traditional)
- Applicant: Advantage Medical Systems, Inc.
- Decided: Oct 23, 1987 after 25 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
- Jul 24, 2017 · Class II · Z-0681-2018: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyve
- Apr 16, 2012 · Not classified · Z-1480-2012: Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device label.

Source page: https://510kreport.com/device/K873957
Methodology: https://510kreport.com/methodology