510(k) · Cleared
ClearedInsuflow Synergy XL Port
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 Aug 22, 2013 as substantially equivalent to K120640 (Lexion Medical, LLC, 2012) and 1 other predicate after a 37-day review. Its family tree reaches back 7 generations to 1997. 3 later devices descend from it.
- Decided
- Aug 22, 2013
- Review
- 37 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K964171 (1997). 34 ancestors in all, the oldest K903419 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 6 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- 5 generations backK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003 · Recalled
- 4 generations backK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- 3 generations backK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- 2 generations backK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
- 1 generation backK120640 Insuflow Synergy PortLexion Medical, LLC · 2012
- This deviceK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
- Descendant · cites it directly · 2 of its ownK140263 Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK170799 AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK191780 AP50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2019
Most influential descendants
Showing 3 of 3 · See all- K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014 · cites it directly2descendants
- K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2017 · 2 generations on1descendant
- K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −6 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| −5 | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | Guidant Corp. | 2003 | 1 |
| −4 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| −3 | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | 4 |
| −2 | K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator… | Surgiquest, Inc. | 2011 | — |
| −1 | K120640 | Insuflow Synergy Port | Lexion Medical, LLC | 2012 | — |
| 0 (this device) | K132204 | Insuflow Synergy XL Port | Lexion Medical, LLC | 2013 | — |
| +1 | K140263 | Insuflow Synergy Port, Insuflow Synergy XL Port | Lexion Medical, LLC | 2014 | — |
| +2 | K170799 | AP 50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2017 | — |
| +3 | K191780 | AP50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 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? (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 |
|---|---|---|---|
| * | K120640 | Insuflow Synergy PortSummary page 1…ION Medical believes that lnsuflow®'SynergyM XL and XLR Port devices are substantially equivalent to the following devices: *Insufiow® SynergyTM Port, K 120640 *EndoPath Xcel Trocar, K032676 Description: The lnsuflow® SynergyTM XL and XLR Port are a gas conditioning de… | 2012 |
| * | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip TrocarSummary page 1…XLR Port devices are substantially equivalent to the following devices: *Insufiow® SynergyTM Port, K 120640 *EndoPath Xcel Trocar, K032676 Description: The lnsuflow® SynergyTM XL and XLR Port are a gas conditioning device that attaches to the outlet port of an insuff… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140263 | Insuflow Synergy Port, Insuflow Synergy XL Port | 2014 | 2 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 34 ancestors have a recall of any class.
- Of its descendants, K140263 (Lexion Medical, LLC, 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K120640.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Insuflow Synergy XL Port (10mm and 12mm) and Insuflow Synergy XLR Port (10mm and 12mm with endoscopic cannula seal) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO₂ gas stream for insufflation of the surgical cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132204: Insuflow Synergy XL Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132204
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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