510(k) · Cleared
ClearedHarioculture TL-16 Time-lapse Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hua Yue Medical Technology Co., Ltd. · MQG Accessory, Assisted Reproduction
Cleared on May 22, 2025 as substantially equivalent to K173264 (Vitrolife A/S, 2018) after a 258-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- May 22, 2025
- Review
- 258 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 deviceK242684 Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd. · 2025
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) | K242684 | Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. | 2025 | — |
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…croscope and Microscope Accessories, Reproduction, Assisted) Regulatory Class: II 4. Predicate Device Information EmbryoScope+ (K173264) manufactured by Vitrolife A/S. The predicate device has not been subject to a design-related recall. 5. Device Description… | 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 21 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. 2025, 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?
Harioculture TL-16 Time-lapse Incubator consists of the following devices with the following indications for use: Time-lapse Incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) or mixed gas (CO2 and other gases) for the development of embryos at or near body temperature. Use of the Time-lapse Incubator is limited to five days (120 hr) covering the time from post insemination to day five of development. The…
Read the full statement (231 words)
Harioculture TL-16 Time-lapse Incubator consists of the following devices with the following indications for use:
Time-lapse Incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) or mixed gas (CO2 and other gases) for the development of embryos at or near body temperature. Use of the Time-lapse Incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.
The Hariomed culture dish is intended for preparing, storing, and transferring human embryos. The Hariomed culture dish must be used together with the Time-lapse Incubator.
The Harioculture-client software is intended for displaying, comparing, storing, and transferring images generated by the Time-lapse Incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The Harioculture-client software does not control any hardware components in the Time-lapse Incubator.
The Harioculture-server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.
The Time-lapse Incubator, Harioculture-client software, and Harioculture-server software must be used together to export embryo images from the Time-lapse Incubator. The Harioculture-client software and Harioculture-server software must be used together to assist users to analyze the embryo images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242684: Harioculture TL-16 Time-lapse Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242684
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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