510(k) · Cleared
ClearedFreezing Medium - Test Yolk Buffer (Tyb) with Glycerol, Refrigeration Medium - Test Yolk Buffer 9TYB)
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 Jul 2, 1999 after a 70-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Jul 2, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK991421 Freezing Medium - Test Yolk Buffer (Tyb) with Glycerol…Irvine Scientific Sales Co., Inc. · 1999
- Descendant · cites it directly · 0 of its ownK192845 Sperm Freeze, Sperm FridgeKitazato Corporation · 2020
Most influential descendants
Showing 1 of 1 · See all- K192845Sperm Freeze, Sperm FridgeKitazato Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991421 | Freezing Medium - Test Yolk Buffer (Tyb) with Glycerol, Refrigeration Medium -… | Irvine Scientific Sales Co., Inc. | 1999 | — |
| +1 | K192845 | Sperm Freeze, Sperm Fridge | Kitazato Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192845 | Sperm Freeze, Sperm Fridge | 2020 | 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?
- Of its descendants, K192845 (Kitazato Corporation, 2020) 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?
Refrigeration Medium — Test Yolk Buffer and Freezing Medium — Test Yolk Buffer with Glycerol are intended for use in assisted reproductive technology procedures that involve the manipulation and storage of semen samples prior to use in in vitro fertilization and other similar treatments. Refrigeration Medium — Test Yolk Buffer is specifically designed for to protect semen samples during refrigerated storage, while Freezing Medium — Test Yolk Buffer with Glycerol is intended to be used as a cryopreservative of semen samples.
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/K991421 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991421: Freezing Medium - Test Yolk Buffer (Tyb) with Glycerol, Refrigeration Medium - Test Yolk Buffer 9TYB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991421
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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