510(k) · Cleared
ClearedSunivf Dishes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
<Genx> Intl., Inc. · MQK Labware, Assisted Reproduction
Cleared on Aug 13, 2008 after a 182-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 13, 2008
- Review
- 182 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 MQK? 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 MQK device
- #1 K241626 SperSort™ Sperm Sorting Chip (IPG02)score 10.1 · 5 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?
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 MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MQK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQK
259in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQK
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQK
1in 2025
MAUDE reports naming product code MQK, 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 | 1 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 3 | 454 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 6 | 270 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 4 | 154 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 4 | 163 | 0 | 0 |
| 2025 | 3 | 259 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SunIVF UniversalTM Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional in-vitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation. The SunFVF Micromanipulation Tm Dish is intended to be used to hold human oocytes and embryos during…
Read the full statement (254 words)
The SunIVF UniversalTM Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional in-vitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation.
The SunFVF Micromanipulation Tm Dish is intended to be used to hold human oocytes and embryos during in-vitro procedures of assisted human reproduction, including fertilization by intracytoplasmic sperm injection, assisted hatching, and biopsy.
The SunIVF ICSFTm Dish is intended to be used to hold human oocytes and sperm during the procedure of fertilization by intracytoplasmic sperm injection.
The SunIVF Freezing Dish 1 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.
The SunIVF Freezing Dish 2 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.
The SunIVF Vitrification Dish is intended to be used to hold human cocytes and embryos during the procedures of vitrification
The SunIVF Rotational Dish is intended to be used to hold human oocytes and embryos during handling and culture.
The SunlVF General Flat Dish - 35 X 10 mm is intended to be used for washing and handling of human oocytes and embryos.
The SunlIVF General Flat Dish - 60 X 15 mm is intended to be used for washing and handling of human oocytes and embryos.
The SunIVF General Flat Dish - 90 X 17 mm is intended to be used for washing and handling of human oocytes and embryos.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080395: Sunivf Dishes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080395
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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