510(k) · Cleared
ClearedModified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgiquest, Inc. · HIF Insufflator, Laparoscopic
Cleared on Jul 3, 2012 as substantially equivalent to K103692 (Surgiquest, Inc., 2011) after a 61-day review. Its family tree reaches back 6 generations to 1997. 4 later devices descend from it.
- Decided
- Jul 3, 2012
- Review
- 61 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K964171 (1997). 24 ancestors in all, the oldest K903419 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 5 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- 4 generations backK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003 · Recalled
- 3 generations backK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- 2 generations backK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- 1 generation backK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
- This deviceK121336 Modified Surgiquest Airseal Optical Trocar & Cannula System with…Surgiquest, Inc. · 2012
- 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
- Descendant · cites it directly · 0 of its ownK132169 Surgiquest Airseal IfsSurgiquest, Inc. · 2013
Most influential descendants
Showing 4 of 4 · 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
- K132169Surgiquest Airseal IfsSurgiquest, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −5 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| −4 | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | Guidant Corp. | 2003 | 1 |
| −3 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| −2 | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | 4 |
| −1 | K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator… | Surgiquest, Inc. | 2011 | — |
| 0 (this device) | K121336 | Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated… | Surgiquest, Inc. | 2012 | — |
| +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 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (1)
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…eal® Optical Trocar & Cannula System with DEVICE(S) integrated Insufflator DPIS2000 SurgiQuest, Inc. (Orange, CT) K103692 DEVICE DESCRIPTION The SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator D… | 2011 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K140263 (Lexion Medical, LLC, 2014) has gone furthest, with 2 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. 2012, 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 Optical Trocar & Cannula System with integrated Insufflator OPIS 2000 (the "OPIS 2000 System") is intended for use in diagnostic and/or therapeutic endloscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endloscopic 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/K121336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121336: Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121336
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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