# K012811: Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B

- Pathway: 510(k) (Traditional)
- Applicant: Humagen Fertility Diagnostics, Inc.
- Decided: Feb 11, 2002 after 173 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: 1 generation back to K990847 (1999). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 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 1.

## Most influential descendants
- K133257: Biopsy Pipettes (2014), 0 descendants of its own
- K102480: Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona Dissection (PZD) Pipette; Assisted HA (2011), 0 descendants of its own
- K092554: Blastomere Biopsy Pipettes, Polar Body Biopsy Pipettes (2010), 0 descendants of its own

## Indications for use
Biopsy micropipets are used to aspirate polar bodies or blastomeres containing genetic material for the purpose or pre-implantation genetic diagnosis. These devices are intended for single use and will be supplied sterile. The labeling will contain the following statement, in prominent and boxed format: “This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their petformance characteristics are determined by individual laboratories for their own use. The performance of these tests may vary depending on the particular assay and disease evaluated. Currently these tests have not been cleared or approved by the Food and Drug Administration.”

Source page: https://510kreport.com/device/K012811
Methodology: https://510kreport.com/methodology