510(k) · Cleared
ClearedInsuflow Device, Model 6198
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 Jan 10, 2007 as substantially equivalent to K970866 (Georgia Biomedical, Inc., 1998) after a 47-day review. Its family tree reaches back 2 generations to 1992. 13 later devices descend from it.
- Decided
- Jan 10, 2007
- Review
- 47 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920986 (1992). 5 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK920986 Snowden-Pencer High Flow Insufflator, SP/88-9700Snowden-Pencer · 1992
- 1 generation backK970866 Filter Heater/Hydrator Insufflation Gas ConditionerGeorgia Biomedical, Inc. · 1998
- This deviceK063546 Insuflow Device, Model 6198Lexion Medical, LLC · 2007
- Descendant · cites it directly · 9 of its ownK090456 InsuflowLexion Medical, LLC · 2009
- Descendant · 2 generations on · 5 of its ownK120640 Insuflow Synergy PortLexion Medical, LLC · 2012
- Descendant · 3 generations on · 3 of its ownK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
- Descendant · 3 generations on · 2 of its ownK140263 Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
- Descendant · cites it directly · 2 of its ownK101320 VasovaporLexion Medical, LLC · 2010
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090456InsuflowLexion Medical, LLC · 2009 · cites it directly9descendants
- K120640Insuflow Synergy PortLexion Medical, LLC · 2012 · 2 generations on5descendants
- K132204Insuflow Synergy XL PortLexion Medical, LLC · 2013 · 3 generations on3descendants
- K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014 · 3 generations on2descendants
- K101320VasovaporLexion Medical, LLC · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700 | Snowden-Pencer | 1992 | — |
| −1 | K970866 | Filter Heater/Hydrator Insufflation Gas Conditioner | Georgia Biomedical, Inc. | 1998 | — |
| 0 (this device) | K063546 | Insuflow Device, Model 6198 | Lexion Medical, LLC | 2007 | — |
| +1 | K090456 | Insuflow | Lexion Medical, LLC | 2009 | — |
| +2 | K120640 | Insuflow Synergy Port | Lexion Medical, LLC | 2012 | — |
| +3 | K132204 | Insuflow Synergy XL Port | Lexion Medical, LLC | 2013 | — |
| +3 | K140263 | Insuflow Synergy Port, Insuflow Synergy XL Port | Lexion Medical, LLC | 2014 | — |
| +1 | K101320 | Vasovapor | Lexion Medical, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K970866 | Filter Heater/Hydrator Insufflation Gas ConditionerSummary page 2…finally flows into the patient's abdomen. Predicate Device: Insufiow® Filter Heater/Hydrator Insufflation Gas Conditioner K970866 Decision Date: January 23, 1998 Summary of Studies: Verification testing included system performance tests designed to… | 1998 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090456 (Lexion Medical, LLC, 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Lexion Medical Insuflow®device is an accessory to an insufflator intended to heat,
humidify and filter a gas stream used for inflation during laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063546: Insuflow Device, Model 6198.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063546
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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