510(k) · Cleared
ClearedBinder CO2 Incubator Serie CB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Binder GmbH · MQG Accessory, Assisted Reproduction
Cleared on Aug 29, 2003 as substantially equivalent to K991408 (Thermoquest Corp., 1999) after a 14-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Aug 29, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991408 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991408 Forma Scientific Universal Water-Jacketed IncubatorThermoquest Corp. · 1999
- This deviceK032526 Binder CO2 Incubator Serie CBBinder GmbH · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991408 | Forma Scientific Universal Water-Jacketed Incubator | Thermoquest Corp. | 1999 | — |
| 0 (this device) | K032526 | Binder CO2 Incubator Serie CB | Binder GmbH | 2003 | — |
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 |
|---|---|---|---|
| * | K991408 | Forma Scientific Universal Water-Jacketed IncubatorSummary page 1…ice: Forma Scientific Universal Water Jacked Incubator (ThermoQuest Corp.) Reference No. K991408, cleared 07/19/1999 Device description: BINDER incubators series CB are bench top or floor standing units. There are two differen… | 1999 |
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?
- Its one ancestor has no recall.
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?
Incubators series CB provide suitable growth-conditions for NaHC03 -buffered cell cultures of ova or embryos with controlled temperature at or near 37°C (98.6"F) and carbon-dioxide atmosphere (optional additionally at hyper oxide or hypo oxide atmosphere) at a high humidity. An automatic dry heat decontamination process of the empty incubator, applicable between different loadings assists to avoid contaminations of the cell cultures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032526: Binder CO2 Incubator Serie CB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032526
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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