# K162881: Kitazato OPU Needles

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: Jul 11, 2017 after 270 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: 3 generations back to K991273 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112462: Kitazato Opu Needle, Kitazato Medical Co., Ltd. (2012). Our reading of the summary gave K112492, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Kitazato OPU Needle with Connection Tube, Type2 and Kitazato OPU…”. Summary page 6.

## Indications for use
The Kitazato OPU Needles consisting of: • Kitazato OPU Needle with Connection Tube (model number Type2) • Kitazato OPU Reduced Needle (model number Type3) • Kitazato OPU Two-Stage Reduced Needle (model number Type4) are intended to obtain oocytes from ovarian follicles.

Source page: https://510kreport.com/device/K162881
Methodology: https://510kreport.com/methodology