510(k) · Cleared
Recalled · Class II · 2026SurgiQuest AirSeal iFS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgiquest, Inc. · HIF Insufflator, Laparoscopic
Cleared on Mar 20, 2015 as substantially equivalent to K103692 (Surgiquest, Inc., 2011) and 1 other predicate after a 112-day review. Its family tree reaches back 7 generations to 1997. 3 of the 57 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it. It has been recalled 11 times.
- Decided
- Mar 20, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- HIF
- Recalls
- 11
- Predicates
- 2
Its longest line of descent runs back 7 generations to K964171 (1997). 29 ancestors in all, the oldest K903419 (1990). 27 later devices descend from it, 2 citing it directly. 3 of the 57 devices in this family, counting this one, have a Class I recall.
- 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 backK110294 High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Recalled (Class I)
- 1 generation backK122180 High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · Recalled (Class I)
- This deviceK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015
- Descendant · cites it directly · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled
- Descendant · 2 generations on · 14 of its ownK201361 PneumoclearW.O.M. World of Medicine GmbH · 2020
- Descendant · 3 generations on · 11 of its ownK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled
- Descendant · cites it directly · 8 of its ownK172516 SurgiQuest AIRSEAL iFS SystemConmed Corporation · 2018
- Descendant · 2 generations on · 5 of its ownK193520 EVA 15 InsufflatorPalliare, Ltd. · 2020
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 27 · See all- K170784PneumoclearW.O.M. World of Medicine GmbH · 2017 · cites it directly17descendants
- K201361PneumoclearW.O.M. World of Medicine GmbH · 2020 · 2 generations on14descendants
- K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc. · 2024 · 3 generations on11descendants
- K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation · 2018 · cites it directly8descendants
- K193520EVA 15 InsufflatorPalliare, Ltd. · 2020 · 2 generations on5descendants
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 | K110294 | High Flow Insufflation Unit Uhi-4 | Olympus Medical Systems Corporation | 2011 | Class I |
| −1 | K122180 | High Flow Insufflantion Unit | Olympus Medical Systems Corporation | 2012 | Class I |
| 0 (this device) | K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015 | — |
| +1 | K170784 | Pneumoclear | W.O.M. World of Medicine GmbH | 2017 | 1 |
| +2 | K201361 | Pneumoclear | W.O.M. World of Medicine GmbH | 2020 | — |
| +3 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with… | Intuitive Surgical, Inc. | 2024 | 6 |
| +1 | K172516 | SurgiQuest AIRSEAL iFS System | Conmed Corporation | 2018 | — |
| +2 | K193520 | EVA 15 Insufflator | Palliare, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 1 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Summary page 4…(Original FDA Clearance as “SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000”, [k103692]. Common Name: Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparo… | 2011 |
| * | K122180 | High Flow Insufflantion UnitSummary page 4…692 (Primary Predicate) “Olympus High Flow Insufflation Unit UHI-4” Olympus Medical Systems, Corp., k122180 (Second Predicate) K143404… | 2012 |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2026 | Class II | Z-2472-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2467-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2469-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2465-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2471-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2474-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2473-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2470-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2466-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2464-2026 | Process change control | Potential for overpressure alerts. |
| May 14, 2026 | Class II | Z-2468-2026 | Process change control | Potential for overpressure alerts. |
The 5 latest of 11 recalls; the web page lists all.
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 29 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K170784 (W.O.M. World of Medicine GmbH, 2017) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K103692.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path…
Read the full statement (108 words)
The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument is used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.
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/K143404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143404: SurgiQuest AirSeal iFS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143404
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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