510(k) · Cleared
Recalled · Class II · 2022Planer BT37 Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planer Plc · MQG Accessory, Assisted Reproduction
Cleared on Nov 29, 2012 as substantially equivalent to K983642 (Cook Ob/Gyn, 1999) after a 184-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Nov 29, 2012
- Review
- 184 days
- Class
- Class II
- Product code
- MQG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983642 (1999). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K191020G210 InviCell Plus with SignipHy pH monitoringCooperSurgical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983642 | Cook Mini-Incubator | Cook Ob/Gyn | 1999 | 3 |
| 0 (this device) | K121566 | Planer BT37 Incubator | Planer Plc | 2012 | — |
| +1 | K191020 | G210 InviCell Plus with SignipHy pH monitoring | CooperSurgical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K983642 | Cook Mini-IncubatorSummary page 1…Incubator Classification Name: Assisted Reproduction Accessory (21 CFR §884,6120) Product Code: MOG Predicate Device: COOK Mini-Incubator (51 0(k) Number: K983642) Device Description: The 8T37 Incubator has been designed as a bench-top incubator to provide a electronically controlled enviro… | 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 |
|---|---|---|---|
| K191020 | G210 InviCell Plus with SignipHy pH monitoring | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2022 | Class II | Z-1822-2022 | Under Investigation by firm | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device… |
| Aug 12, 2022 | Class II | Z-1823-2022 | Under Investigation by firm | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized 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. 2012, this device’s year, is highlighted.
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 Planer BT37 Incubator is intended to be used to provide an environment with controlled temperature at or near body temperature, CO2, O2 and N2 gases, and elevated humidity for the development of gametes and embryos during in vitro fertilization (IVF) /assisted reproductive technology (ART) treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121566: Planer BT37 Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121566
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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