510(k) · Cleared
ClearedHeal Force CO2 Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Lishen Scientific Equipment Co., Ltd. · MQG Accessory, Assisted Reproduction
Cleared on Feb 8, 2011 as substantially equivalent to K002805 (Kendro Laboratory Products, L.P., 2000) and 1 other predicate after a 209-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Feb 8, 2011
- Review
- 209 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002805 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K002805 | Kendro Heracell CO2 IncubatorSummary page 1…cessory, Assisted Reproduction Predicate Devices: Predicate Manufactur& K Number Submitted Device Model Kendro FORMA K002805 HF90 Heracell SCIENTIFIC, INC C02 Incubator- H ERAceII___________ Kendra FORMA… | 2000 |
| * | K023465 | Kendro Heracell 240 IncubatorSummary page 1…cell SCIENTIFIC, INC C02 Incubator- H ERAceII___________ Kendra FORMA HF240 Heracell SCIENTIFIC, INC K023465 C02 Incubator- HERAceII ________________ 14 of 336 3. Cla… | 2003 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K002805.
How does its category compare?
All MQG devicesMQG Accessory, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
For Models HF9O, HF240, the intended use of these incubators is to
provide an environment with controlled temperature, C02 elevated
humidity, and an automatic disinfection mode, 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/K101988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101988: Heal Force CO2 Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101988
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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