# K052561: Terumo Micro Tapered Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Kofu Factory of Terumo Corp.
- Decided: Nov 23, 2005 after 65 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 K955235 (1996). 2 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 20 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.
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 2.

## Most influential descendants
- K063466: Top Fine (2007), 11 descendants of its own
- K100812: Ulticare Disposable Pen Needles (2010), 9 descendants of its own
- K140516: Terumo Pen Injector Needle 34 (2014), 4 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

## Indications for use
The TERUMO® Micro tapered pen needle is intended for use with a pen injector device for the subcutaneous injection of insulin. It is indicated for general use and for pediatric patients.

Source page: https://510kreport.com/device/K052561
Methodology: https://510kreport.com/methodology