# K030469: Laparoshield Conditioned Insufflation Set

- Pathway: 510(k) (Traditional)
- Applicant: Pall Medical
- Decided: May 9, 2003 after 86 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.
14 later devices descend from it; 1 cites it directly.
0 of 15 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 its predicate without a number.
- (no number) Georgia BioMedical System, Inc.’s Filter HeatedHydrator Insufflation Gas Conditioner (“Insuflow”): named in the summary without a submission number

## Most influential descendants
- K052125: Carbonaid Gas Diffuser (2006), 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
- K140263: Insuflow Synergy Port, Insuflow Synergy XL Port (2014), 2 descendants of its own

## Indications for use
The Laparoshield Conditioned Insufflation Set is intended for use as an accessory to an insufflator to heat, humidify, and filter a gas stream used for insufflation during laparoscopic surgery. The device is indicated for use with C02.

Source page: https://510kreport.com/device/K030469
Methodology: https://510kreport.com/methodology