# K112462: Kitazato Opu Needle

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Medical Co., Ltd.
- Decided: Nov 26, 2012 after 458 days
- Product code: MQE (Needle, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6100
- 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 K991273 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082727: Follicle Aspiration Set, Reduced Single Lumen, Vitrolife Sweden AB (2009) Summary page 2.
- K991273: Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle, Swemed Lab International AB (1999) Summary page 2.

## Most influential descendants
- K162881: Kitazato OPU Needles (2017), 0 descendants of its own

## Indications for use
The Kitazato OPU Needles consisting of: * Kitazato OPU Needle with Connection Tube, model number Type 2 * Kitazato OPU Reduced Needle, model number Type 3 are intended to obtain oocytes from ovarian follicles.

Source page: https://510kreport.com/device/K112462
Methodology: https://510kreport.com/methodology