510(k) · Cleared
ClearedKendro Heracell 240 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 Mar 10, 2003 as substantially equivalent to K002805 (Kendro Laboratory Products, L.P., 2000) after a 146-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Mar 10, 2003
- Review
- 146 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002805 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK002805 Kendro Heracell CO2 IncubatorKendro Laboratory Products, L.P. · 2000
- This deviceK023465 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
Most influential descendants
Showing 1 of 1 · See all- K101988Heal Force CO2 IncubatorShanghai Lishen Scientific Equipment Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002805 | Kendro Heracell CO2 Incubator | Kendro Laboratory Products, L.P. | 2000 | — |
| 0 (this device) | K023465 | Kendro Heracell 240 Incubator | Kendro Laboratory Products, L.P. | 2003 | — |
| +1 | K101988 | Heal Force CO2 Incubator | Shanghai Lishen Scientific Equipment Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K002805 | Kendro Heracell CO2 Incubator Our reading of the summary gave K002505, FDA’s number for Xia Spine System (Howmedica Osteonics Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Kendro HEMcell CO2 Incubator”. | 2000 |
| † | K991408 | Forma Scientific Universal Water-Jacketed Incubator | 1999 |
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 |
|---|---|---|---|
| K101988 | Heal Force CO2 Incubator | 2011 | 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?
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 this incubator is to provide an environment with controlled temperature, CO2, elevated humidity, an automatic decontamination mode, and O2 at suppressed levels, for the development of ova or embryos at or near body temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023465: Kendro Heracell 240 Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023465
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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