# K102480: Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona Dissection (PZD) Pipette; Assisted HA

- Pathway: 510(k) (Traditional)
- Applicant: Jieying Laboratory, Inc.
- Decided: Apr 19, 2011 after 232 days
- Product code: MQH (Microtools, Assisted Reproduction (Pipettes))
- Device class: 2
- Regulation: 21 CFR 884.6130
- 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 K990847 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990847: Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M, Humagen Fertility Diagnostics, Inc. (1999) Summary page 2.
- K012811: Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B, Humagen Fertility Diagnostics, Inc. (2002) Summary page 2.

## Indications for use
Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI). Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy. Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s) Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from oocytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s). Tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation Tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically. Tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos.

Source page: https://510kreport.com/device/K102480
Methodology: https://510kreport.com/methodology