510(k) · Cleared
ClearedInsuflow Dewheart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lexion Medical, LLC · HIF Insufflator, Laparoscopic
Cleared on Sep 3, 2009 as substantially equivalent to K063546 (Lexion Medical, LLC, 2007) and 2 other predicates after a 118-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Sep 3, 2009
- Review
- 118 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K920986 (1992). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK920986 Snowden-Pencer High Flow Insufflator, SP/88-9700Snowden-Pencer · 1992
- 2 generations backK970866 Filter Heater/Hydrator Insufflation Gas ConditionerGeorgia Biomedical, Inc. · 1998
- 1 generation backK063546 Insuflow Device, Model 6198Lexion Medical, LLC · 2007
- This deviceK091366 Insuflow DewheartLexion Medical, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700 | Snowden-Pencer | 1992 | — |
| −2 | K970866 | Filter Heater/Hydrator Insufflation Gas Conditioner | Georgia Biomedical, Inc. | 1998 | — |
| −1 | K063546 | Insuflow Device, Model 6198 | Lexion Medical, LLC | 2007 | — |
| 0 (this device) | K091366 | Insuflow Dewheart | Lexion Medical, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 HIF? 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 HIF device
- #1 K250388 Endoflator +score 15.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K063546 | Insuflow Device, Model 6198Summary page 1…2. Equivalent devices LEXION Medical believes that Insuflow® DewHeartTm is substantially equivalent to the following devices: LnsuflowO, K063 546 CarbonAid, K052125 CTS Blower Mister, K983 135 Insuflow® DewHeartrm is technically the same dev… | 2007 |
| * | K052125 | Carbonaid Gas DiffuserSummary page 1…LEXION Medical believes that Insuflow® DewHeartTm is substantially equivalent to the following devices: LnsuflowO, K063 546 CarbonAid, K052125 CTS Blower Mister, K983 135 Insuflow® DewHeartrm is technically the same device as the Insuflow®~gas conditio… | 2006 |
| * | K983135 | Blower/MisterSummary page 1…wHeartTm is substantially equivalent to the following devices: LnsuflowO, K063 546 CarbonAid, K052125 CTS Blower Mister, K983 135 Insuflow® DewHeartrm is technically the same device as the Insuflow®~gas conditioner insuffator accessory device clea… | 1998 |
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 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 4 other devices also cite its predicate K063546.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HIF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIF
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIF
12so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HIF
1,507in 2025
MAUDE reports naming product code HIF, 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 | 4 | 140 | 0 | 8 |
| 2008 | 2 | — | 1 | 14 |
| 2009 | 4 | 191 | 0 | 21 |
| 2010 | 2 | — | 0 | 41 |
| 2011 | 5 | 128 | 0 | 44 |
| 2012 | 5 | 138 | 0 | 38 |
| 2013 | 2 | — | 0 | 40 |
| 2014 | 2 | — | 0 | 43 |
| 2015 | 2 | — | 0 | 30 |
| 2016 | 3 | 88 | 1 | 72 |
| 2017 | 5 | 242 | 0 | 68 |
| 2018 | 3 | 207 | 1 | 97 |
| 2019 | 2 | — | 0 | 128 |
| 2020 | 4 | 64 | 0 | 360 |
| 2021 | 1 | — | 0 | 654 |
| 2022 | 1 | — | 0 | 667 |
| 2023 | 7 | 134 | 1 (1) | 890 |
| 2024 | 4 | 170 | 0 | 1,483 |
| 2025 | 3 | 210 | 0 | 1,507 |
| 2026 | 3 | 265 | 12 | — |
What is it indicated for?
The Insuflow®DewHeart TM is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO 2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091366 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091366: Insuflow Dewheart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091366
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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