510(k) · Cleared
ClearedSage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Origio A/S · MQL Media, Reproductive
Cleared on Apr 16, 2014 as substantially equivalent to K112083 (<Genx> Intl., Inc., 2012) after a 133-day review. Its family tree reaches back 1 generation to 2012. 2 later devices descend from it.
- Decided
- Apr 16, 2014
- Review
- 133 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K112083 (2012). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK112083 Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total…<Genx> Intl., Inc. · 2012
- This deviceK133707 Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein…Origio A/S · 2014
- Descendant · cites it directly · 0 of its ownK220715 ARTSMedia In Vitro Culture Medium (AM-IVC Medium)Artsmedia Denmark Aps · 2023
- Descendant · cites it directly · 0 of its ownK172197 SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSOrigio A/S · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112083 | Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total… | <Genx> Intl., Inc. | 2012 | — |
| 0 (this device) | K133707 | Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements | Origio A/S | 2014 | — |
| +1 | K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium) | Artsmedia Denmark Aps | 2023 | — |
| +1 | K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | Origio A/S | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K112083 | Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total W/HepesSummary page 1…eproductive media and supplements (21 CFR 884.6180, Product Code MQL) Predicate device: LifeGlobal: LifeGlobal Global® Total" (K1 12083). Description The SAGE 1-StepTM medium is intended for in vitro fertilization and culture of human gametes and embryos from fert… | 2012 |
| † | K121572 | Continuous Single Culture Complete | 2012 |
| † | K081114 | G-1 V5 | 2008 |
| † | K081117 | G-2 V5 | 2008 |
| † | K031015 | Embryoglue | 2003 |
| † | K002836 | Media for Gamete Preparation and Embryo Culture | 2000 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K220715 (Artsmedia Denmark Aps, 2023) has gone furthest, with 0 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. 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?
These products are intended for the in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The media can also be used for transfer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133707: Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133707
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