# K950466: B-D Ultra-Fine II Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: May 11, 1995 after 97 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.
101 later devices descend from it; 1 cites it directly.
0 of 102 devices 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.

## Most influential descendants
- K021475: BD Single Lumen Needle, Syringe and Blood Collection Set (2002), 100 descendants of its own
- K070440: BD Hypoint Needle (2007), 91 descendants of its own
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own
- K110421: Disposable Insulin Syringe (2011), 36 descendants of its own
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own

Source page: https://510kreport.com/device/K950466
Methodology: https://510kreport.com/methodology