510(k) · Cleared
Recalled · Class II · 2022Biopsy Medium, Model Ref 1062
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicult A/S · MQL Media, Reproductive
Cleared on Jul 28, 2006 as substantially equivalent to K021358 (Irvine Scientific Sales Co., Inc., 2002) and 1 other predicate after a 109-day review. Its family tree reaches back 1 generation to 2002. It has been recalled once.
- Decided
- Jul 28, 2006
- Review
- 109 days
- Class
- Class II
- Product code
- MQL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021358 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK021358 Embryo Biopsy MediumIrvine Scientific Sales Co., Inc. · 2002
- This deviceK060983 Biopsy Medium, Model Ref 1062Medicult A/S · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021358 | Embryo Biopsy Medium | Irvine Scientific Sales Co., Inc. | 2002 | — |
| 0 (this device) | K060983 | Biopsy Medium, Model Ref 1062 | Medicult A/S | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQL device
- #1 K251305 Ultra-Fast Vitri; Ultra-Fast Warmscore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021358 | Embryo Biopsy MediumSummary page 1…Biopsy Medium Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL) Predicate device: Embryo Biopsy Medium from Irvine Scientific (K021358) and the Sydney lVF Embryo Biopsy Medium from Cook (K023850). Description MediCult Biopsy Medium is a defined sterile media used… | 2002 |
| * | K023850 | Sydney Ivf Embryo Biopsy MediumSummary page 1…pplements (21 CFR 884.6180, Product Code MQL) Predicate device: Embryo Biopsy Medium from Irvine Scientific (K021358) and the Sydney lVF Embryo Biopsy Medium from Cook (K023850). Description MediCult Biopsy Medium is a defined sterile media used by professionals within assisted reproduction and designed… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2022 | Class II | Z-1044-2023 | Labeling Change Control | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K021358.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQL
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQL
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQL
3in 2025
MAUDE reports naming product code MQL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 212 | 0 | 0 |
| 2008 | 12 | 151 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 235 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 253 | 1 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 5 | 142 | 0 | 3 |
| 2015 | 7 | 87 | 0 | 0 |
| 2016 | 12 | 170 | 0 | 2 |
| 2017 | 10 | 113 | 0 | 0 |
| 2018 | 4 | 94 | 0 | 0 |
| 2019 | 6 | 170 | 0 | 0 |
| 2020 | 8 | 257 | 1 | 0 |
| 2021 | 1 | — | 2 | 0 |
| 2022 | 3 | 316 | 1 | 0 |
| 2023 | 5 | 199 | 1 | 1 |
| 2024 | 12 | 195 | 0 | 6 |
| 2025 | 9 | 225 | 0 | 3 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
Biopsy Medium is indicated for blastomere biopsy of cleavage stage embryos for PGD (pre-implantation genetic diagnosis)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060983: Biopsy Medium, Model Ref 1062.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060983
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026