# K022643: Blastomere Biopsy Pipette, Models H-55530 and H-55540

- Pathway: 510(k) (Traditional)
- Applicant: Swemed Lab International AB
- Decided: Nov 5, 2002 after 89 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Assisted Hatching/Zona Drilling Pipette component of Swemed's Follicle Aspiration Set: named in the summary without a submission number
- (no number) Cook OB/GYN's Pre-Implantation Genetic Diagnosis Pipette: named in the summary without a submission number
- (no number) Humagen Fertility Diagnostics, Inc.'s Blastomere Biopsy Micropipette: named in the summary without a submission number

## Indications for use
The Swemed Blastomere Biopsy Pipette is intended to conduct a blastomere biopsy, which may be done in order to perform pre-implantation genetic diagnosis on the genetic material in the biopsied cell(s). The Swemed Blastomere Biopsy Pipette is indicated to aspirate blastomeres containing genetic material for the purpose of pre-implantation genetic diagnosis. This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PIGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by the 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/K022643
Methodology: https://510kreport.com/methodology