510(k) · Cleared
ClearedVessel Guardian
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 Nov 10, 2011 as substantially equivalent to K102136 (Lexion Medical, LLC, 2010) and 1 other predicate after an 86-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Nov 10, 2011
- Review
- 86 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K920986 (1992). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK920986 Snowden-Pencer High Flow Insufflator, SP/88-9700Snowden-Pencer · 1992
- 5 generations backK970866 Filter Heater/Hydrator Insufflation Gas ConditionerGeorgia Biomedical, Inc. · 1998
- 4 generations backK063546 Insuflow Device, Model 6198Lexion Medical, LLC · 2007
- 3 generations backK090456 InsuflowLexion Medical, LLC · 2009
- 2 generations backK101320 VasovaporLexion Medical, LLC · 2010
- 1 generation backK102136 Vessel GuardianLexion Medical, LLC · 2010
- This deviceK112357 Vessel GuardianLexion Medical, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700 | Snowden-Pencer | 1992 | — |
| −5 | K970866 | Filter Heater/Hydrator Insufflation Gas Conditioner | Georgia Biomedical, Inc. | 1998 | — |
| −4 | K063546 | Insuflow Device, Model 6198 | Lexion Medical, LLC | 2007 | — |
| −3 | K090456 | Insuflow | Lexion Medical, LLC | 2009 | — |
| −2 | K101320 | Vasovapor | Lexion Medical, LLC | 2010 | — |
| −1 | K102136 | Vessel Guardian | Lexion Medical, LLC | 2010 | — |
| 0 (this device) | K112357 | Vessel Guardian | Lexion Medical, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 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? (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 |
|---|---|---|---|
| * | K102136 | Vessel GuardianSummary page 1…HIF 2. Equivalent devices LEXION Medical believes that Vessel VaporTM is substantially equivalent to the following devices: Vessel Guardian®, K102136 lnsuflow®, K090456 Vessel VaporM is the same gas conditioner insufflator accessory device and has the same… | 2010 |
| * | K090456 | InsuflowSummary page 1…LEXION Medical believes that Vessel VaporTM is substantially equivalent to the following devices: Vessel Guardian®, K102136 lnsuflow®, K090456 Vessel VaporM is the same gas conditioner insufflator accessory device and has the same intended use as the predicate… | 2009 |
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 19 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Vessel VaporTM is a gas conditioner accessory device intended to heat, humidify and filter an insufflating CO2 gas stream being used in minimally invasive cardiovascular, thoracoscopic, and vessel harvesting surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112357: Vessel Guardian.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112357
Report an extraction error
Are you the manufacturer?
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