510(k) · Cleared
ClearedBlastfreeze and Blastthaw
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 Jun 27, 2003 as substantially equivalent to K991471 (Medicult A/S, 2000) after a 46-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jun 27, 2003
- Review
- 46 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991471 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK991471 Medi-Cult Blastocyst Freezing & Thawing Packs, Internal Catalog…Medicult A/S · 2000
- This deviceK031486 Blastfreeze and BlastthawMedicult A/S · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991471 | Medi-Cult Blastocyst Freezing & Thawing Packs, Internal Catalog Numbers (1012… | Medicult A/S | 2000 | — |
| 0 (this device) | K031486 | Blastfreeze and Blastthaw | Medicult A/S | 2003 | — |
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? (1)
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 |
|---|---|---|---|
| * | K991471 | Medi-Cult Blastocyst Freezing & Thawing Packs, Internal Catalog Numbers (1012, 1015)Summary page 2…se is shown in the present submission and the products are substantially equivalent to the predicated devices, our Blastocyst Freezing Pack and Blastocyst Thawing Pack ( K 991471) R & R REGISTRATIONS P.O. Box 262069 San Diego, Ca 92 I3 1 858-586-075 1… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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?
For freezing of human blastocysts.
For thawing of human blastocysts
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031486: Blastfreeze and Blastthaw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031486
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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