# K242536: TauTona Pneumoperitoneum Assist Device (TPAD)

- Pathway: 510(k) (Traditional)
- Applicant: Tautona Group
- Decided: Oct 15, 2024 after 50 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
Longest line of descent: 4 generations back to K852726 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233020: TauTona Pneumoperitoneum Assist Device (TPAD), Tautona Group Research & Development, Co., LLC (2024) Summary page 5.

## Indications for use
The TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use with the Veress Needle for the establishment of a pneumoperitoneum during laparoscopic procedures.

Source page: https://510kreport.com/device/K242536
Methodology: https://510kreport.com/methodology