# K070988: SC Profi Fine Pen Needle, Models; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)

- Pathway: 510(k) (Traditional)
- Applicant: Shinchang Medical Co., Ltd.
- Decided: Aug 23, 2007 after 139 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
Longest line of descent: 1 generation back to K002938 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002938: B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16, Bd Becton Dickinson Vacutainer Systems Preanalytic (2000) Summary page 2.
- K031200: Modification to BD Ultra-Fine Iii Pen Needle, Becton, Dickinson & CO (2003) Summary page 2.

## Indications for use
The SC Profi Fine pen needle is intended for use with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

Source page: https://510kreport.com/device/K070988
Methodology: https://510kreport.com/methodology