510(k) · Cleared
ClearedEnhance-S Plus H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conception Technology, Inc. · MQL Media, Reproductive
Cleared on Feb 12, 2003 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Feb 12, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK030116 Enhance-S Plus HConception Technology, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK053494 Oil for Tissue Culture, Gradient System and SpermfreezeFertipro NV · 2006
- Descendant · 2 generations on · 0 of its ownK191552 GM501 Mineral OilHamilton Thorne, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK043494 Mastel Laser Clean Room, Model Ebs-100Mastel Precision Surgical Instruments, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K053494Oil for Tissue Culture, Gradient System and SpermfreezeFertipro NV · 2006 · cites it directly1descendant
- K191552GM501 Mineral OilHamilton Thorne, Inc. · 2019 · 2 generations on0descendants
- K043494Mastel Laser Clean Room, Model Ebs-100Mastel Precision Surgical Instruments, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030116 | Enhance-S Plus H | Conception Technology, Inc. | 2003 | — |
| +1 | K053494 | Oil for Tissue Culture, Gradient System and Spermfreeze | Fertipro NV | 2006 | — |
| +2 | K191552 | GM501 Mineral Oil | Hamilton Thorne, Inc. | 2019 | — |
| +1 | K043494 | Mastel Laser Clean Room, Model Ebs-100 | Mastel Precision Surgical Instruments, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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, K053494 (Fertipro NV, 2006) has gone furthest, with 1 descendant 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?
Cell isolation media used for separation and purification of hunian sperm for assisted reproduction procedures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030116 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030116: Enhance-S Plus H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030116
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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