# K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Feb 12, 1996 after 90 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
153 later devices descend from it; 10 cite it directly.
0 of 154 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
- K992802: Terumo U-100 Insulin Syringe (1999), 84 descendants of its own
- K071630: Terumo 31G Thinpro Insulin Syringe (2007), 82 descendants of its own
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own

## Recalls of this device
- Oct 22, 2004 · Not classified · Z-0569-05: Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).

Source page: https://510kreport.com/device/K955235
Methodology: https://510kreport.com/methodology