510(k) · Cleared
ClearedHI-Flo Therme Pneu 45, Wisap #7083, 7083V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · HIF Insufflator, Laparoscopic
Cleared on Jun 27, 2003 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 48 devices in its family, counting itself, have a Class I recall. 47 later devices descend from it.
- Decided
- Jun 27, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 2 citing it directly. 2 of the 48 devices in this family, counting this one, have a Class I recall.
- This deviceK031014 HI-Flo Therme Pneu 45, Wisap #7083, 7083VWisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · 2003
- Descendant · cites it directly · 44 of its ownK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- Descendant · 2 generations on · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
- Descendant · 2 generations on · 32 of its ownK110294 High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 31 of its ownK122180 High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 47 · See all- K06336745L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · cites it directly44descendants
- K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011 · 2 generations on35descendants
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 2 generations on32descendants
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 3 generations on31descendants
- K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031014 | HI-Flo Therme Pneu 45, Wisap #7083, 7083V | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 2003 | — |
| +1 | 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 | — |
| +2 | K110294 | High Flow Insufflation Unit Uhi-4 | Olympus Medical Systems Corporation | 2011 | Class I |
| +3 | K122180 | High Flow Insufflantion Unit | Olympus Medical Systems Corporation | 2012 | Class I |
| +3 | K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015 | 11 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (47)
See all 472 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K063367 (W.O.M. World of Medicine AG, 2007) has gone furthest, with 44 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.
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 WISAP Multi Hi-Flo Therme Pneu 45 may only be used for building up a pneumoperitoneum with CO2 Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031014 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031014: HI-Flo Therme Pneu 45, Wisap #7083, 7083V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031014
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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