# K063466: Top Fine

- Pathway: 510(k) (Traditional)
- Applicant: Daejin Tech Medical Manufacturing Co., Ltd.
- Decided: Mar 2, 2007 after 106 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: 2 generations back to K973899 (1997). 6 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033575: One.Click Needle, B.Braun Medical, Inc. (2004) Summary page 1.
- K052561: Terumo Micro Tapered Pen Needle, Kofu Factory of Terumo Corp. (2005) Summary page 1.
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005) Summary page 1.

## Most influential descendants
- K100812: Ulticare Disposable Pen Needles (2010), 9 descendants of its own
- K113186: Sterile Insulin Pen Needle (2012), 4 descendants of its own
- K133100: Carefine Pen Needle (2014), 3 descendants of its own
- K210748: Well-life TM Pen Needles, Well-life TM Safety Pen Needles (2022), 1 descendant of its own
- K152877: SureFine Pen Needle (2016), 1 descendant of its own

## Indications for use
The Top Fine® disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes..

Source page: https://510kreport.com/device/K063466
Methodology: https://510kreport.com/methodology