510(k) · Cleared
ClearedFlow-Therme, Wisap #7642
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Aug 25, 1995 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 16 later devices descend from it.
- Decided
- Aug 25, 1995
- Review
- 86 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK952508 Flow-Therme, Wisap #7642Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · 1995
- Descendant · cites it directly · 14 of its ownK970866 Filter Heater/Hydrator Insufflation Gas ConditionerGeorgia Biomedical, Inc. · 1998
- Descendant · 2 generations on · 13 of its ownK063546 Insuflow Device, Model 6198Lexion Medical, LLC · 2007
- Descendant · 3 generations on · 9 of its ownK090456 InsuflowLexion Medical, LLC · 2009
- Descendant · 4 generations on · 5 of its ownK120640 Insuflow Synergy PortLexion Medical, LLC · 2012
- Descendant · 5 generations on · 3 of its ownK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K970866Filter Heater/Hydrator Insufflation Gas ConditionerGeorgia Biomedical, Inc. · 1998 · cites it directly14descendants
- K063546Insuflow Device, Model 6198Lexion Medical, LLC · 2007 · 2 generations on13descendants
- K090456InsuflowLexion Medical, LLC · 2009 · 3 generations on9descendants
- K120640Insuflow Synergy PortLexion Medical, LLC · 2012 · 4 generations on5descendants
- K132204Insuflow Synergy XL PortLexion Medical, LLC · 2013 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952508 | Flow-Therme, Wisap #7642 | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 1995 | — |
| +1 | K970866 | Filter Heater/Hydrator Insufflation Gas Conditioner | Georgia Biomedical, Inc. | 1998 | — |
| +2 | K063546 | Insuflow Device, Model 6198 | Lexion Medical, LLC | 2007 | — |
| +3 | K090456 | Insuflow | Lexion Medical, LLC | 2009 | — |
| +4 | K120640 | Insuflow Synergy Port | Lexion Medical, LLC | 2012 | — |
| +5 | K132204 | Insuflow Synergy XL Port | Lexion Medical, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (16)
See all 162 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?
- Of its descendants, K970866 (Georgia Biomedical, Inc., 1998) has gone furthest, with 14 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952508: Flow-Therme, Wisap #7642.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952508
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026