# K955073: Ksea Thermoflator (Model 26 4320 20)

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Dec 6, 1996 after 396 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K991906: Laparo CO2-Pneu Automatic Insufflator with 30L Flow Rate,and Video-Screen Display, High Flow Insufflation Tube with Heat (1999), 0 descendants of its own

## Indications for use
This device is designed to carefully deliver large flow rates for rapid insufflation, and monitor the amounts of CO₂ gas needed to establish and maintain proper distention of the peritoneal cavity during Ob/Gyn laparoscopic surgical and diagnostic procedures

Source page: https://510kreport.com/device/K955073
Methodology: https://510kreport.com/methodology