# K060983: Biopsy Medium, Model Ref 1062

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Jul 28, 2006 after 109 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021358 (2002). 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)
- K021358: Embryo Biopsy Medium, Irvine Scientific Sales Co., Inc. (2002) Summary page 1.
- K023850: Sydney Ivf Embryo Biopsy Medium, Cook Ob/Gyn (2003) Summary page 1.

## Recalls of this device
- Dec 15, 2022 · Class II · Z-1044-2023: The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.

## Indications for use
Biopsy Medium is indicated for blastomere biopsy of cleavage stage embryos for PGD (pre-implantation genetic diagnosis)

Source page: https://510kreport.com/device/K060983
Methodology: https://510kreport.com/methodology