510(k) · Cleared
Recalled · Class II · 201945L Core Insufflator, Model F114
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine AG · HIF Insufflator, Laparoscopic
Cleared on May 23, 2007 as substantially equivalent to K060723 (W.O.M. World of Medicine AG, 2006) and 3 other predicates after a 197-day review. Its family tree reaches back 4 generations to 1997. 2 of the 59 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it. It has been recalled 4 times.
- Decided
- May 23, 2007
- Review
- 197 days
- Class
- Class II
- Product code
- HIF
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 4 generations to K964171 (1997). 14 ancestors in all, the oldest K904993 (1991). 44 later devices descend from it, 7 citing it directly. 2 of the 59 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 3 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- 2 generations backK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003 · Recalled
- 1 generation backK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- This deviceK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007
- Descendant · cites it directly · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
- Descendant · cites it directly · 32 of its ownK110294 High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 31 of its ownK122180 High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled
- Descendant · cites it directly · 22 of its ownK120151 Nebulae INorthgate Technologies, Inc. · 2012 · Recalled
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 44 · See all- K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011 · cites it directly35descendants
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · cites it directly32descendants
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 2 generations on31descendants
- K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · 2 generations on27descendants
- K120151Nebulae INorthgate Technologies, Inc. · 2012 · cites it directly22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −3 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| −2 | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | Guidant Corp. | 2003 | 1 |
| −1 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| 0 (this device) | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | — |
| +1 | K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator… | Surgiquest, Inc. | 2011 | — |
| +1 | K110294 | High Flow Insufflation Unit Uhi-4 | Olympus Medical Systems Corporation | 2011 | Class I |
| +2 | K122180 | High Flow Insufflantion Unit | Olympus Medical Systems Corporation | 2012 | Class I |
| +2 | K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015 | 11 |
| +1 | K120151 | Nebulae I | Northgate Technologies, Inc. | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 1 |
| 2012 | 4 | 1 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 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.
2 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? (4)
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 |
|---|---|---|---|
| * | K060723 | 40 L High Flow Insufflator F113Summary page 1…pe, 21 C.F.R. § 876.1500 Regulatory Class: H1 Product Code: HIP / GCJ Predicate Devices: 1. 40 LHigh FlowlInsufflator F113, (K060723) 2. HI-FLO Thermne Pneu 45, (K03 1014) 3. Stryker Heated Insufflator Tube S… | 2006 |
| * | K031014 | HI-Flo Therme Pneu 45, Wisap #7083, 7083VSummary page 1…: H1 Product Code: HIP / GCJ Predicate Devices: 1. 40 LHigh FlowlInsufflator F113, (K060723) 2. HI-FLO Thermne Pneu 45, (K03 1014) 3. Stryker Heated Insufflator Tube Set, (K003792) 4. Surgiflator 20, Singl… | 2003 |
| * | K003792 | Stryker Heated Insufflator Tube SetSummary page 1…igh FlowlInsufflator F113, (K060723) 2. HI-FLO Thermne Pneu 45, (K03 1014) 3. Stryker Heated Insufflator Tube Set, (K003792) 4. Surgiflator 20, Single-Use Heatable Tube Set, (K950035) Device Desc… | 2001 |
| * | K950035 | Surgiflator 20Summary page 1…3. Stryker Heated Insufflator Tube Set, (K003792) 4. Surgiflator 20, Single-Use Heatable Tube Set, (K950035) Device Description: The 45L CORE Insuflator F114 is a microprocessor controlled C02 insuffator designed… | 1996 |
What descends from it? (44)
See all 447 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 | 2011 | 35 |
| K110294 | High Flow Insufflation Unit Uhi-4 Class I | 2011 | 32 |
| K120151 | Nebulae I | 2012 | 22 |
| K153513 | Insufflator 50L FM134 | 2016 | 21 |
| K190303 | AirSeal | 2019 | 1 |
| K170799 | AP 50/30 Insufflator with Insuflow Port | 2017 | 1 |
| K230239 | AirSeal iFS System; AirSeal dV Solution | 2023 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2019 | Class II | Z-1726-2019 | Under Investigation by firm | The heated tube sets were consistently leaking and detaching from the cassette. |
| Mar 7, 2019 | Class II | Z-1727-2019 | Under Investigation by firm | The heated tube sets were consistently leaking and detaching from the cassette. |
| Mar 28, 2016 | Class II | Z-1566-2016 | Nonconforming Material/Component | When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display… |
| Dec 29, 2008 | Not classified | Z-1198-2010 | Component design/selection | Unexpected powering down/failure to boot up: A problem with a transistor in the heater/temperature sensor component in the device may cause the device to power off during surgery or to fail to boot up at all. The risk includes delay and… |
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.
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K103692 (Surgiquest, Inc., 2011) has gone furthest, with 35 descendants of its own.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 45L CORE Insufflator F114 is a C02 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application, the low flow application and the bariatric application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F114 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063367: 45L Core Insufflator, Model F114.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063367
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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