510(k) · Cleared
ClearedSurgiquest Airseal Ifs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgiquest, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 22, 2013 as substantially equivalent to K103692 (Surgiquest, Inc., 2011) and 1 other predicate after a 38-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Aug 22, 2013
- Review
- 38 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K964171 (1997). 25 ancestors in all, the oldest K903419 (1990). No later device cites it as a predicate yet.
- 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 backK121336 Modified Surgiquest Airseal Optical Trocar & Cannula System with…Surgiquest, Inc. · 2012
- This deviceK132169 Surgiquest Airseal IfsSurgiquest, Inc. · 2013
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 | K121336 | Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated… | Surgiquest, Inc. | 2012 | — |
| 0 (this device) | K132169 | Surgiquest Airseal Ifs | Surgiquest, Inc. | 2013 | — |
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 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 1…Trocar & Cannula System with DEVICE(S) integrated Insufflator DPIS2000 SurgiQuest, Inc. (Orange, CT) K103 692 Modified SurgiQuest AirSeal® Optical Trocar & Cannula System with Integrated… | 2011 |
| * | K121336 | Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator…Summary page 1…rocar & Cannula System with Integrated Insufflator DPIS 2000 SurgiQuest, Inc. (Milford, CT) K121336 DEVICE DESCRIPTION The SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insu… | 2012 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 25 ancestors have a recall of any class.
- 4 other devices also cite its predicate K103692.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneall cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132169 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132169: Surgiquest Airseal Ifs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132169
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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