510(k) · Cleared
Recalled · Class II · 2020Cook Mini-Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ob/Gyn · MQG Accessory, Assisted Reproduction
Cleared on Feb 1, 1999 after a 108-day review. The FDA summary names no predicate by number. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 1, 1999
- Review
- 108 days
- Class
- Class II
- Product code
- MQG
- Recalls
- 3
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK983642 Cook Mini-IncubatorCook Ob/Gyn · 1999
- Descendant · cites it directly · 11 of its ownK092183 Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011
- Descendant · 2 generations on · 9 of its ownK111715 EmbryoscopeUnisense Fertilitech A/S · 2011
- Descendant · 2 generations on · 8 of its ownK113075 Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011
- Descendant · 2 generations on · 4 of its ownK150961 EmbryoSlide Culture DishVitrolife A/S · 2015
- Descendant · 3 generations on · 4 of its ownK133712 Embryoviewer SoftwareUnisense Fertilitech A/S · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K092183Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011 · cites it directly11descendants
- K111715EmbryoscopeUnisense Fertilitech A/S · 2011 · 2 generations on9descendants
- K113075Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011 · 2 generations on8descendants
- K150961EmbryoSlide Culture DishVitrolife A/S · 2015 · 2 generations on4descendants
- K133712Embryoviewer SoftwareUnisense Fertilitech A/S · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983642 | Cook Mini-Incubator | Cook Ob/Gyn | 1999 | — |
| +1 | K092183 | Embryoscope and Embryoslide | Unisense Fertilitech A/S | 2011 | — |
| +2 | K111715 | Embryoscope | Unisense Fertilitech A/S | 2011 | — |
| +2 | K113075 | Embryo Viewer Software | Unisense Fertilitech A/S | 2011 | — |
| +2 | K150961 | EmbryoSlide Culture Dish | Vitrolife A/S | 2015 | — |
| +3 | K133712 | Embryoviewer Software | Unisense Fertilitech A/S | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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?
The FDA summary names no predicate by number.
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2020 | Class II | Z-0809-2021 | Under Investigation by firm | A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator. |
| Jan 12, 2018 | Class II | Z-1377-2018 | Device Design | The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater. |
| Jan 12, 2018 | Class II | Z-1378-2018 | Device Design | The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092183 (Unisense Fertilitech A/S, 2011) has gone furthest, with 11 descendants of its own.
How does its category compare?
All MQG devicesMQG Accessory, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 COOK Mini-Incubator is intended to be used to store and
preserve gametes and/or embryos at or near body temperature.
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/K983642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983642: Cook Mini-Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983642
Report an extraction error
Are you the manufacturer?
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