# K133257: Biopsy Pipettes

- Pathway: 510(k) (Traditional)
- Applicant: Research Instruments, Ltd.
- Decided: May 16, 2014 after 205 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). 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)
- K991261: Icsi Injection Micropipette (Spiked & Non-Spiked), Icsi Holding Miceopipette, Assisted Hatching/Zona Drilling Micropipet, Research Instruments, Ltd. (1999) Summary page 1.
- 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 1.

## Indications for use
Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).

Source page: https://510kreport.com/device/K133257
Methodology: https://510kreport.com/methodology