510(k) · Cleared
ClearedG-TL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife, Inc. · MQL Media, Reproductive
Cleared on Jul 16, 2014 as substantially equivalent to K121572 (Irvine Scientific Sales Co., Inc., 2012) after a 238-day review. Its family tree reaches back 3 generations to 2004. 4 later devices descend from it.
- Decided
- Jul 16, 2014
- Review
- 238 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K034063 (2004). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK034063 Multiblast MediumIrvine Scientific Sales Co., Inc. · 2004
- 2 generations backK072609 Single Step MediumIrvine Scientific Sales Co., Inc. · 2008
- 1 generation backK121572 Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012
- This deviceK133568 G-TLVitrolife, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK191063 1-Step Culture MediumShenzhen Vitavitro Biotech Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK202862 Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB · 2021
- Descendant · 2 generations on · 0 of its ownK193285 V-OnestepVitromed GmbH · 2020
- Descendant · cites it directly · 0 of its ownK161261 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium…Genea Biomedx Pty, Ltd. · 2017
Most influential descendants
Showing 4 of 4 · See all- K1910631-Step Culture MediumShenzhen Vitavitro Biotech Co., Ltd. · 2019 · cites it directly1descendant
- K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB · 2021 · cites it directly0descendants
- K193285V-OnestepVitromed GmbH · 2020 · 2 generations on0descendants
- K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst…Genea Biomedx Pty, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K034063 | Multiblast Medium | Irvine Scientific Sales Co., Inc. | 2004 | — |
| −2 | K072609 | Single Step Medium | Irvine Scientific Sales Co., Inc. | 2008 | — |
| −1 | K121572 | Continuous Single Culture Complete | Irvine Scientific Sales Co., Inc. | 2012 | — |
| 0 (this device) | K133568 | G-TL | Vitrolife, Inc. | 2014 | — |
| +1 | K191063 | 1-Step Culture Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2019 | — |
| +1 | K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | Vitrolife Sweden AB | 2021 | — |
| +2 | K193285 | V-Onestep | Vitromed GmbH | 2020 | — |
| +1 | K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems… | Genea Biomedx Pty, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 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? (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 |
|---|---|---|---|
| * | K121572 | Continuous Single Culture CompleteSummary page 1…ification: Class 11Reproductive Media and Supplements (CRF 844.6180; Product Code MOL) Predicate Device: CSC'" Complete (K121572) K133568 Name: G4LMvtoW K133568… | 2012 |
| † | K033462 | Early Cleavage Medium (Ecm) | 2004 |
| † | K034063 | Multiblast Medium | 2004 |
| † | K022244 | G-1 Version 3, Model 10048 | 2002 |
| † | K021890 | G-2 Version 3, Model 10049 | 2002 |
| † | K081114 | G-1 V5 | 2008 |
| † | K081117 | G-2 V5 | 2008 |
| † | K080473 | Embryoassist and Embryoassist with Phenol Red | 2008 |
| † | K080172 | Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref… | 2008 |
What descends from it? (4)
3 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191063 (Shenzhen Vitavitro Biotech Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K121572.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
Medium for culture of embryos from fertilization to blastocyst stage
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133568: G-TL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133568
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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