# K242772: AirSurgN Insufflator (10030/AirSurgN)

- Pathway: 510(k) (Traditional)
- Applicant: SmartsurgN, Inc.
- Decided: Apr 11, 2025 after 210 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: 9 generations back to K964171 (1997). 34 ancestors in all.
No later device cites it as a predicate yet.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170784: Pneumoclear, W.O.M. World of Medicine GmbH (2017) Summary page 5.

## Indications for use
The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the abdominal cavity and maintain pneumoperitoneum by filling it with carbon dioxide (CO2) gas. The AirSurgN Insufflator provides user-selectable variable CO2 gas flow and pressure rates.

Source page: https://510kreport.com/device/K242772
Methodology: https://510kreport.com/methodology