510(k) · Cleared
ClearedAP 50/30 Insufflator with Insuflow 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 Nov 14, 2017 as substantially equivalent to K063367 (W.O.M. World of Medicine AG, 2007) and 2 other predicates after a 242-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it.
- Decided
- Nov 14, 2017
- Review
- 242 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K964171 (1997). 40 ancestors in all, the oldest K903419 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 5 generations between
- 3 generations backK120640 Insuflow Synergy PortLexion Medical, LLC · 2012
- 2 generations backK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
- 1 generation backK140263 Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
- This deviceK170799 AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2017
- Descendant · cites it directly · 0 of its ownK191780 AP50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2019
Show all 9 generations
- Root · 9 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 8 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- 7 generations backK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003 · Recalled
- 6 generations backK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- 5 generations backK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- 4 generations backK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
- 3 generations backK120640 Insuflow Synergy PortLexion Medical, LLC · 2012
- 2 generations backK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
- 1 generation backK140263 Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
- This deviceK170799 AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −8 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| −7 | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | Guidant Corp. | 2003 | 1 |
| −6 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| −5 | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | 4 |
| −4 | K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator… | Surgiquest, Inc. | 2011 | — |
| −3 | K120640 | Insuflow Synergy Port | Lexion Medical, LLC | 2012 | — |
| −2 | K132204 | Insuflow Synergy XL Port | Lexion Medical, LLC | 2013 | — |
| −1 | K140263 | Insuflow Synergy Port, Insuflow Synergy XL Port | Lexion Medical, LLC | 2014 | — |
| 0 (this device) | K170799 | AP 50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2017 | — |
| +1 | 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 | 5 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K063367 | 45L Core Insufflator, Model F114Summary page 4…nsufflator with Insuflow® Port devices is substantially equivalent to the following devices: • Primary Predicate: Stryker/WOM 45L CORE Insufflator F114, K063367 • WOM Insufflator 50L FM134, K153513 • Lexion Insuflow® Synergy™ Port and Synergy™ XL Port, K14… | 2007 |
| * | K153513 | Insufflator 50L FM134Summary page 4…y equivalent to the following devices: • Primary Predicate: Stryker/WOM 45L CORE Insufflator F114, K063367 • WOM Insufflator 50L FM134, K153513 • Lexion Insuflow® Synergy™ Port and Synergy™ XL Port, K140263 None of the cited predicate devices have been su… | 2016 |
| * | K140263 | Insuflow Synergy Port, Insuflow Synergy XL PortSummary page 4…yker/WOM 45L CORE Insufflator F114, K063367 • WOM Insufflator 50L FM134, K153513 • Lexion Insuflow® Synergy™ Port and Synergy™ XL Port, K140263 None of the cited predicate devices have been subject to a design-related recall. Description: The Lexion AP50/30 Insufflator i… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191780 | AP50/30 Insufflator with Insuflow Port | 2019 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 40 ancestors have a recall of any class.
- Of its descendants, K191780 (Lexion Medical, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K063367.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting…
Read the full statement (136 words)
The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.
The Insuflow® Port (5 mm, 8 mm, 10mm and 12mm) devices 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170799 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170799: AP 50/30 Insufflator with Insuflow Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170799
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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