510(k) · Cleared
ClearedEmbryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Huchuang Union Technology Co., Ltd. · MQG Accessory, Assisted Reproduction
Cleared on May 7, 2024 as substantially equivalent to K173264 (Vitrolife A/S, 2018) after a 264-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- May 7, 2024
- Review
- 264 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K040717 (2004). 9 ancestors in all, the oldest K983642 (1999). No later device cites it as a predicate yet.
- Root · 7 generations backK040717 Nunc Ivf Multidish 4 Wells NunclonNunc A/S · 2004
- 6 generations backK070047 Nunc Ivf Dishes and Nunc Ivf 4-Well DishNunc A/S · 2007
- 5 generations backK092183 Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011
- 4 generations backK111715 EmbryoscopeUnisense Fertilitech A/S · 2011
- 3 generations backK113075 Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011
- 2 generations backK133712 Embryoviewer SoftwareUnisense Fertilitech A/S · 2014
- 1 generation backK173264 EmbryoScope+Vitrolife A/S · 2018
- This deviceK232493 Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish…Wuhan Huchuang Union Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K040717 | Nunc Ivf Multidish 4 Wells Nunclon | Nunc A/S | 2004 | — |
| −6 | K070047 | Nunc Ivf Dishes and Nunc Ivf 4-Well Dish | Nunc A/S | 2007 | — |
| −5 | K092183 | Embryoscope and Embryoslide | Unisense Fertilitech A/S | 2011 | — |
| −4 | K111715 | Embryoscope | Unisense Fertilitech A/S | 2011 | — |
| −3 | K113075 | Embryo Viewer Software | Unisense Fertilitech A/S | 2011 | — |
| −2 | K133712 | Embryoviewer Software | Unisense Fertilitech A/S | 2014 | — |
| −1 | K173264 | EmbryoScope+ | Vitrolife A/S | 2018 | — |
| 0 (this device) | K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | Wuhan Huchuang Union Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2015 | 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 MQG? 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 MQG device
- #1 K261083 Wallace® Aspiration Pump (WAPV1); Wallace®…score 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173264 | EmbryoScope+Summary page 5…eproduction), MQK (Labware, Assisted Reproduction), MTX (Microscope and Microscope Accessories, Reproduction, Assisted) IV. Predicate Device EmbryoScope+ (K173264) manufactured by Vitrolife A/S The predicate device has not been subject to any design related recalls. V. Device Descriptio… | 2018 |
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 20 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 2 other devices also cite its predicate K173264.
How does its category compare?
All MQG devicesMQG Accessory, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MQG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQG
135in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQG
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQG
1in 2025
MAUDE reports naming product code MQG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 137 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 236 | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 135 | 0 | 0 |
| 2019 | 0 | — | 1 | 2 |
| 2020 | 0 | — | 1 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 3 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Embryo Real-time Incubator (TLS301) is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Embryo Real-time Incubator (TLS301) has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours. The Embryo Real-time Culture Dish (MC 2004) is intended for preparing, storing and transferring human embryos. It is…
Read the full statement (236 words)
The Embryo Real-time Incubator (TLS301) is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Embryo Real-time Incubator (TLS301) has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.
The Embryo Real-time Culture Dish (MC 2004) is intended for preparing, storing and transferring human embryos. It is intended to be used only with the Embryo Real-time Incubator (TLS301).
Embryo Realtime 2S Software and Embryo Realtime 3E Software are optional software accessories for the Embryo Real-time Incubator (TLS301).
The Embryo Realtime 2S Software is intended to store, archive and transfer data. In addition, the Embryo Realtime 25 Software includes functions for managing models and performing calculations based on image data and embryo development parameters.
Embryo Realtime 3E Software is intended for viewing and recording embryo development events from images captured using the Embryo Real-time Incubator (TLS301). Embryo Realtime 3E Software includes a user annotation function for capturing information on embryo development parameters and a user-defined modeling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection.
Embryo Realtime 2S Software and Embryo Realtime 3E Software do not control any hardware components in the Embryo Real-time Incubator (TLS301). Embryo Realtime 2S Software and Embryo Realtime 3E Software are provided in different software package and must be used together.
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/K232493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232493: Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232493
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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