510(k) · Cleared
ClearedMultiblast Medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Scientific Sales Co., Inc. · MQL Media, Reproductive
Cleared on Apr 26, 2004 after a 117-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Apr 26, 2004
- Review
- 117 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK034063 Multiblast MediumIrvine Scientific Sales Co., Inc. · 2004
- Descendant · cites it directly · 9 of its ownK072609 Single Step MediumIrvine Scientific Sales Co., Inc. · 2008
- Descendant · 2 generations on · 8 of its ownK121572 Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK133568 G-TLVitrolife, Inc. · 2014
- Descendant · 4 generations on · 1 of its ownK191063 1-Step Culture MediumShenzhen Vitavitro Biotech Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK170681 Continuous Single Culture -NX (CSCM-NX)Irvine Scientific Sales Co., Inc. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072609Single Step MediumIrvine Scientific Sales Co., Inc. · 2008 · cites it directly9descendants
- K121572Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012 · 2 generations on8descendants
- K133568G-TLVitrolife, Inc. · 2014 · 3 generations on4descendants
- K1910631-Step Culture MediumShenzhen Vitavitro Biotech Co., Ltd. · 2019 · 4 generations on1descendant
- K170681Continuous Single Culture -NX (CSCM-NX)Irvine Scientific Sales Co., Inc. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K034063 | Multiblast Medium | Irvine Scientific Sales Co., Inc. | 2004 | — |
| +1 | K072609 | Single Step Medium | Irvine Scientific Sales Co., Inc. | 2008 | — |
| +2 | K121572 | Continuous Single Culture Complete | Irvine Scientific Sales Co., Inc. | 2012 | — |
| +3 | K133568 | G-TL | Vitrolife, Inc. | 2014 | — |
| +4 | K191063 | 1-Step Culture Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2019 | — |
| +3 | K170681 | Continuous Single Culture -NX (CSCM-NX) | Irvine Scientific Sales Co., Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 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?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 112 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, K072609 (Irvine Scientific Sales Co., Inc., 2008) has gone furthest, with 9 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 | — |
What is it indicated for?
MultiBlast Medium is intended for use in the culture of human embryos to the blastocyst stage of development.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034063 · printed Nov 4, 2026
Cite this page
510(k) Report. “K034063: Multiblast Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034063
Report an extraction error
Are you the manufacturer?
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