510(k) · Cleared
ClearedSanyo CO2 Incubators, Models Nos. Mco-17AC, Mco-17AIC, Mco-20AIC,and MC0-175M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanyo North America Corp. · MQG Accessory, Assisted Reproduction
Cleared on Dec 14, 2001 as substantially equivalent to K001524 (Thermoquest Corp., 2000) and 1 other predicate after a 36-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Dec 14, 2001
- Review
- 36 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001524 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK001524 Forma Scientific Direct Heat IncubatorsThermoquest Corp. · 2000
- This deviceK013703 Sanyo CO2 Incubators, Models Nos. Mco-17AC, Mco-17AIC, Mco-20AIC,and…Sanyo North America Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001524 | Forma Scientific Direct Heat Incubators | Thermoquest Corp. | 2000 | — |
| 0 (this device) | K013703 | Sanyo CO2 Incubators, Models Nos. Mco-17AC, Mco-17AIC, Mco-20AIC,and MC0-175M | Sanyo North America Corp. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K001524 | Forma Scientific Direct Heat IncubatorsSummary page 1…n Number & Classification ProCode Name 21 CFR § § 884.6120 Embryo Incubator/Assisted ProCode 85 MQG Reproduction Accessory CO, Incubators cleared for ThermoQuest Corp. (K001524, 7/12/2000) and Kendro Laboratory Products, L.P. (K002805, 11/9/00). One of the subject devices provides a model equipped with U… | 2000 |
| * | K002805 | Kendro Heracell CO2 IncubatorSummary page 1…Embryo Incubator/Assisted ProCode 85 MQG Reproduction Accessory CO, Incubators cleared for ThermoQuest Corp. (K001524, 7/12/2000) and Kendro Laboratory Products, L.P. (K002805, 11/9/00). One of the subject devices provides a model equipped with UV-based decontamination control, as opposed to either HEPA… | 2000 |
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?
- None of the 2 ancestors has a 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?
To provide an environment with controlled temperature, CO;, (and other gases), and elevated humidity for the development of ova or embryos.
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/K013703 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013703: Sanyo CO2 Incubators, Models Nos. Mco-17AC, Mco-17AIC, Mco-20AIC,and MC0-175M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013703
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026