510(k) · Cleared
ClearedModified Ham's F-10 Basal Medium, Modified Hams's F-10 Basal Medium Hepes, Modified Ham's F-10 Supplement (50X) Iyophili
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 Sep 14, 1999 after a 144-day review. The FDA summary names no predicate by number.
- Decided
- Sep 14, 1999
- Review
- 144 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
No later submission names this one as a predicate yet.
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.
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?
Complete Modified Ham's F-10 Medium and Complete Modified Ham's F-10 Medium HEPES are intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, Complete Modified Ham’s F-10 Medium is intended for use as a culture medium for the embryo after fertilization, when used with an incubator, and as a medium to support in vitro fertilization. Complete Modified Ham’s F-10 Medium HEPES is…
Read the full statement (148 words)
Complete Modified Ham's F-10 Medium and Complete Modified Ham's F-10 Medium HEPES are intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, Complete Modified Ham’s F-10 Medium is intended for use as a culture medium for the embryo after fertilization, when used with an incubator, and as a medium to support in vitro fertilization. Complete Modified Ham’s F-10 Medium HEPES is intended for use as a sperm-processing medium in washing or ICSt-# - procedures, as an cocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo. Both Modified Ham’s F-10 Medium and Modified Ham's F-10 Medium HEPES are supplied to customers as liquid basal media and 50X lyophilized supplements. Users are instructed to reconstitute the lyophilized supplement with the basal liquid media to form the complete media at the time of use.
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/K991419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991419: Modified Ham's F-10 Basal Medium, Modified Hams's F-10 Basal Medium Hepes, Modified Ham's F-10 Supplement (50X) Iyophili.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991419
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026