# K952508: Flow-Therme, Wisap #7642

- Pathway: 510(k) (Traditional)
- Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
- Decided: Aug 25, 1995 after 86 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K970866: Filter Heater/Hydrator Insufflation Gas Conditioner (1998), 14 descendants of its own
- K063546: Insuflow Device, Model 6198 (2007), 13 descendants of its own
- K090456: Insuflow (2009), 9 descendants of its own
- K120640: Insuflow Synergy Port (2012), 5 descendants of its own
- K132204: Insuflow Synergy XL Port (2013), 3 descendants of its own

Source page: https://510kreport.com/device/K952508
Methodology: https://510kreport.com/methodology