# K031200: Modification to BD Ultra-Fine Iii Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Jun 24, 2003 after 69 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Ultra-Fine Pen Needle: named in the summary without a submission number
- (no number) BD Ultra-Fine I11 Pen Needle: named in the summary without a submission number

## Most influential descendants
- K143437: Droplet Pen Needles (2015), 4 descendants of its own
- K171982: Droplet Pen Needle (2018), 3 descendants of its own
- K260739: Profoject™ Pen Needles (Model A; Model B) (2026), 0 descendants of its own
- K230635: Pen Needle (2023), 0 descendants of its own
- K192464: Injection Pen Needle (2020), 0 descendants of its own

## Indications for use
Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K031200
Methodology: https://510kreport.com/methodology