510(k) · Cleared
ClearedAP50/30 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 Aug 28, 2019 as substantially equivalent to K170799 (Lexion Medical, LLC, 2017) and 1 other predicate after a 57-day review. Its family tree reaches back 10 generations to 1997. 3 of the 49 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 28, 2019
- Review
- 57 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K964171 (1997). 48 ancestors in all, the oldest K903419 (1990). No later device cites it as a predicate yet. 3 of the 49 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 6 generations between
- 3 generations backK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
- 2 generations backK140263 Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
- 1 generation backK170799 AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2017
- This deviceK191780 AP50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2019
Show all 10 generations
- Root · 10 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 9 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- 8 generations backK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003 · Recalled
- 7 generations backK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- 6 generations backK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- 5 generations backK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
- 4 generations backK120640 Insuflow Synergy PortLexion Medical, LLC · 2012
- 3 generations backK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
- 2 generations backK140263 Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
- 1 generation backK170799 AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2017
- This deviceK191780 AP50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2019
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −9 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| −8 | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | Guidant Corp. | 2003 | 1 |
| −7 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| −6 | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | 4 |
| −5 | K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator… | Surgiquest, Inc. | 2011 | — |
| −4 | K120640 | Insuflow Synergy Port | Lexion Medical, LLC | 2012 | — |
| −3 | K132204 | Insuflow Synergy XL Port | Lexion Medical, LLC | 2013 | — |
| −2 | K140263 | Insuflow Synergy Port, Insuflow Synergy XL Port | Lexion Medical, LLC | 2014 | — |
| −1 | K170799 | AP 50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2017 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 1 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 1 |
| 2012 | 3 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K170799 | AP 50/30 Insufflator with Insuflow PortSummary page 4…nsufflator with Insuflow® Port devices is substantially equivalent to the following devices: • Primary Predicate: AP50/30 Insufflator with Insuflow Port, K170799 • Secondary Predicate: PNEUMOCLEAR Insufflator, K170784 None of the cited predicate devices have been subject to… | 2017 |
| * | K170784 | PneumoclearSummary page 4…e following devices: • Primary Predicate: AP50/30 Insufflator with Insuflow Port, K170799 • Secondary Predicate: PNEUMOCLEAR Insufflator, K170784 None of the cited predicate devices have been subject to a design-related recall. Description: The Lexion AP50/30 Insufflator i… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 3 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 4 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
- K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 11 of the 48 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 (159 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 TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery.
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 as stated in the FDA summary.
https://510kreport.com/device/K191780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191780: AP50/30 Insufflator with Insuflow Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191780
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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