510(k) · Cleared
ClearedOil for Tissue Culture, Gradient System and Spermfreeze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fertipro NV · MQL Media, Reproductive
Cleared on Mar 23, 2006 as substantially equivalent to K011462 (Conception Technologies, 2001) and 2 other predicates after a 98-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Mar 23, 2006
- Review
- 98 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K011462 (2001). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K191552GM501 Mineral OilHamilton Thorne, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011462 | Oil for Tissue Culture | Conception Technologies | 2001 | — |
| 0 (this device) | K053494 | Oil for Tissue Culture, Gradient System and Spermfreeze | Fertipro NV | 2006 | — |
| +1 | K191552 | GM501 Mineral Oil | Hamilton Thorne, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K011462 | Oil for Tissue CultureSummary page 2…o Reproductive Media Bundle ’ 79 Fegeirn The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]: Device Ref# Decided OIL FOR TISSUE CULTURE K011462 06/13/2001 ENHANCE-S PLUS H K030116 02/12/2003 ENHANCE SPERM FREEZE K030117 03/20/2003 Description of the devices: 0il For Tissu… | 2001 |
| * | K030116 | Enhance-S Plus HSummary page 2…geirn The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]: Device Ref# Decided OIL FOR TISSUE CULTURE K011462 06/13/2001 ENHANCE-S PLUS H K030116 02/12/2003 ENHANCE SPERM FREEZE K030117 03/20/2003 Description of the devices: 0il For Tissue Culture is a colorless liquid para… | 2003 |
| * | K030117 | Enhance Sperm FreezeSummary page 2…hich we are claiming equivalence [807.92(a)(3)]: Device Ref# Decided OIL FOR TISSUE CULTURE K011462 06/13/2001 ENHANCE-S PLUS H K030116 02/12/2003 ENHANCE SPERM FREEZE K030117 03/20/2003 Description of the devices: 0il For Tissue Culture is a colorless liquid paraffin. Gradient System is a solution of… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191552 | GM501 Mineral Oil | 2019 | 0 |
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?
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?
Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K053494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053494: Oil for Tissue Culture, Gradient System and Spermfreeze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053494
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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