# K113712: IM-11 Pneumatic Microinjector

- Pathway: 510(k) (Traditional)
- Applicant: Narishige Co., Ltd.
- Decided: Mar 15, 2012 after 87 days
- Product code: MQJ (Micromanipulators And Microinjectors, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6150
- 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 K001910 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001910: IM-9C Microinjectors, Narishige Co., Ltd. (2000) Summary page 1.

## Most influential descendants
- K142207: TransferMan 4m Micromanipulator (2015), 0 descendants of its own

## Indications for use
The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into oocytes, and to hold oocytes during the ICSI procedure.

Source page: https://510kreport.com/device/K113712
Methodology: https://510kreport.com/methodology