510(k) · Cleared
Cleared<Genx> Fertilization Media-HTF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
<Genx> Intl., Inc. · MQL Media, Reproductive
Cleared on Jul 19, 1999 as substantially equivalent to K962816 (Genx Intl., Inc., 1996) and 1 other predicate after a 103-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Jul 19, 1999
- Review
- 103 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K861188 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861188 | Sperm Capacitation Medium | Irvine Scientific | 1987 | — |
| −1 | K962816 | Sperm Preparation Media | Genx Intl., Inc. | 1996 | — |
| 0 (this device) | K991173 | <Genx> Fertilization Media-HTF | <Genx> Intl., Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962816 | Sperm Preparation MediaSummary page 2…{fi\ <genX> HTF Media is similar to a number of mediums currently available in the marketplace. This product is substantially equivalent to our Sperm Capacitation Media (K962816), the Irvine Sperm Washing Media (K872102), Irvine Capacitation Media (K861166/A) in the following ways: 1. They have the same… | 1996 |
| * | K872102 | Sperm Washing Medium #9932Summary page 2…er of mediums currently available in the marketplace. This product is substantially equivalent to our Sperm Capacitation Media (K962816), the Irvine Sperm Washing Media (K872102), Irvine Capacitation Media (K861166/A) in the following ways: 1. They have the same intended use. 2. They are of the same ori… | 1987 |
| Kept off the family tree | K861166 | FDA’s K861166 is Oxygen Therapy Regulator or Regulator-Flowmeter Our OCR of the scanned summary read K861166, FDA’s number for Oxygen Therapy Regulator or Regulator-Flowmeter (Victor). Its FDA name has none of the distinctive words the summary uses for the device it names, “Irvine Capacitation Media”. Kept off the family tree. Summary page 2…he marketplace. This product is substantially equivalent to our Sperm Capacitation Media (K962816), the Irvine Sperm Washing Media (K872102), Irvine Capacitation Media (K861166/A) in the following ways: 1. They have the same intended use. 2. They are of the same original formula. The formulation of thi… | 1986 |
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.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 3 ancestors has a 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?
HTF Media is used as a general purpose media. May be used in procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (1Ul). It may also be used as a holding media at the time of retrieval of the gametes and for the holding of the oocytes in day 1 and 2, prior to transfer. The indications for use of this media is based on the general procedures for…
Read the full statement (115 words)
HTF Media is used as a general purpose media. May be used in procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (1Ul).
It may also be used as a holding media at the time of retrieval of the gametes and for the holding of the oocytes in day 1 and 2, prior to transfer.
The indications for use of this media is based on the general procedures for preparation of semen for Intrauterine Insemination described by Paul S. Weatherbee, Ph.D. and Lawrence B. Werlin, M.D., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of California, Irvine Medical Center.
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/K991173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991173: <Genx> Fertilization Media-HTF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991173
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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