510(k) · Cleared
ClearedHTF Medium, Modified HTF Medium- Hepes, HTF Powder (Without Antibiotics), Modified HTG Powder- Hepes (Without Antiboditi
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 Feb 18, 1999 after a 128-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Feb 18, 1999
- Review
- 128 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK983586 HTF Medium, Modified HTF Medium- Hepes, HTF Powder (Without…Irvine Scientific Sales Co., Inc. · 1999
- Descendant · cites it directly · 0 of its ownK242640 FertiCult Flushing medium; FertiCult Flushing medium with phenol red…Fertipro NV · 2025
- Descendant · cites it directly · 0 of its ownK121128 Multipurpose Handling MediumIrvine Scientific Sales Co., Inc. · 2012
- Descendant · cites it directly · 0 of its ownK993484 Q-HTF, Cat# 2001Invitrocare, Inc. · 2000
Most influential descendants
Showing 3 of 3 · See all- K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV · 2025 · cites it directly0descendants
- K121128Multipurpose Handling MediumIrvine Scientific Sales Co., Inc. · 2012 · cites it directly0descendants
- K993484Q-HTF, Cat# 2001Invitrocare, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983586 | HTF Medium, Modified HTF Medium- Hepes, HTF Powder (Without Antibiotics)… | Irvine Scientific Sales Co., Inc. | 1999 | — |
| +1 | K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and… | Fertipro NV | 2025 | — |
| +1 | K121128 | Multipurpose Handling Medium | Irvine Scientific Sales Co., Inc. | 2012 | — |
| +1 | K993484 | Q-HTF, Cat# 2001 | Invitrocare, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2012 | 1 | 0 |
| 2025 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
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?
- Of its descendants, K242640 (Fertipro NV, 2025) 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.
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?
HTF and Modified HTF are intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, HTF 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. Modified HTF is intended for use as a sperm-processing medium in washing procedures, as an oocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo. Both HTF and Modified HTF are intended to simulate the substances found in the human, female reproductive system.
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/K983586 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983586: HTF Medium, Modified HTF Medium- Hepes, HTF Powder (Without Antibiotics), Modified HTG Powder- Hepes (Without Antiboditi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983586
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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