510(k) · Cleared
ClearedBlastassist System
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 Mar 22, 2001 after a 163-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Mar 22, 2001
- Review
- 163 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK003156 Blastassist SystemMedicult A/S · 2001
- Descendant · cites it directly · 3 of its ownK061309 EmbryoassistMedicult A/S · 2007
- Descendant · cites it directly · 2 of its ownK080172 Blastassist Without Phenol Red, Model Ref 1215, Blastassist with…Medicult A/S · 2008
- Descendant · 2 generations on · 2 of its ownK080473 Embryoassist and Embryoassist with Phenol RedMedicult A/S · 2008
- Descendant · 2 generations on · 1 of its ownK133387 Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with…Origio A/S · 2014
- Descendant · 3 generations on · 1 of its ownK120136 EmbryogenOrigio A/S · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K061309EmbryoassistMedicult A/S · 2007 · cites it directly3descendants
- K080172Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref…Medicult A/S · 2008 · cites it directly2descendants
- K080473Embryoassist and Embryoassist with Phenol RedMedicult A/S · 2008 · 2 generations on2descendants
- K133387Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol RedOrigio A/S · 2014 · 2 generations on1descendant
- K120136EmbryogenOrigio A/S · 2012 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003156 | Blastassist System | Medicult A/S | 2001 | — |
| +1 | K061309 | Embryoassist | Medicult A/S | 2007 | — |
| +1 | K080172 | Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red… | Medicult A/S | 2008 | — |
| +2 | K080473 | Embryoassist and Embryoassist with Phenol Red | Medicult A/S | 2008 | — |
| +2 | K133387 | Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol Red | Origio A/S | 2014 | — |
| +3 | K120136 | Embryogen | Origio A/S | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K061309 (Medicult A/S, 2007) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K003156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003156: Blastassist System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003156
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026