510(k) · Cleared
ClearedKendro Heracell CO2 Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendro Laboratory Products, L.P. · MQG Accessory, Assisted Reproduction
Cleared on Nov 9, 2000 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 9, 2000
- Review
- 62 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK002805 Kendro Heracell CO2 IncubatorKendro Laboratory Products, L.P. · 2000
- Descendant · cites it directly · 1 of its ownK023465 Kendro Heracell 240 IncubatorKendro Laboratory Products, L.P. · 2003
- Descendant · cites it directly · 0 of its ownK101988 Heal Force CO2 IncubatorShanghai Lishen Scientific Equipment Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK013703 Sanyo CO2 Incubators, Models Nos. Mco-17AC, Mco-17AIC, Mco-20AIC,and…Sanyo North America Corp. · 2001
Most influential descendants
Showing 3 of 3 · See all- K023465Kendro Heracell 240 IncubatorKendro Laboratory Products, L.P. · 2003 · cites it directly1descendant
- K101988Heal Force CO2 IncubatorShanghai Lishen Scientific Equipment Co., Ltd. · 2011 · cites it directly0descendants
- K013703Sanyo CO2 Incubators, Models Nos. Mco-17AC, Mco-17AIC, Mco-20AIC,and MC0-175MSanyo North America Corp. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002805 | Kendro Heracell CO2 Incubator | Kendro Laboratory Products, L.P. | 2000 | — |
| +1 | K023465 | Kendro Heracell 240 Incubator | Kendro Laboratory Products, L.P. | 2003 | — |
| +1 | K101988 | Heal Force CO2 Incubator | Shanghai Lishen Scientific Equipment Co., Ltd. | 2011 | — |
| +1 | K013703 | Sanyo CO2 Incubators, Models Nos. Mco-17AC, Mco-17AIC, Mco-20AIC,and MC0-175M | Sanyo North America Corp. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023465 (Kendro Laboratory Products, L.P., 2003) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K002805 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002805: Kendro Heracell CO2 Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002805
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026