# K092554: Blastomere Biopsy Pipettes, Polar Body Biopsy Pipettes

- Pathway: 510(k) (Traditional)
- Applicant: Sunlight Medical, Inc.
- Decided: Apr 30, 2010 after 253 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)
- 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
The Blastomere Biopsy Pipettes are tools 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). The Polar Body Biopsy Pipettes are tools used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

Source page: https://510kreport.com/device/K092554
Methodology: https://510kreport.com/methodology