510(k) · Cleared
ClearedForma Scientific Universal Water-Jacketed Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermoquest Corp. · MQG Accessory, Assisted Reproduction
Cleared on Jul 19, 1999 after an 88-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Jul 19, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK991408 Forma Scientific Universal Water-Jacketed IncubatorThermoquest Corp. · 1999
- Descendant · cites it directly · 0 of its ownK032526 Binder CO2 Incubator Serie CBBinder GmbH · 2003
Most influential descendants
Showing 1 of 1 · See all- K032526Binder CO2 Incubator Serie CBBinder GmbH · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991408 | Forma Scientific Universal Water-Jacketed Incubator | Thermoquest Corp. | 1999 | — |
| +1 | K032526 | Binder CO2 Incubator Serie CB | Binder GmbH | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032526 | Binder CO2 Incubator Serie CB | 2003 | 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, K032526 (Binder GmbH, 2003) has gone furthest, with 0 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 intended use of these incubators is to provide an environment with controlled temperature, CO, and an elevated humidity, for the development of ova or embryos. Certain models also control O, at suppressed levels.
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/K991408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991408: Forma Scientific Universal Water-Jacketed Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991408
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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