# K091441: Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: Oct 30, 2009 after 168 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911808 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990518: Peregrine Wet Set, Model PD400.00, Peregrine Surgical, Ltd. (1999) Summary page 1.
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 2.

## Indications for use
The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.

Source page: https://510kreport.com/device/K091441
Methodology: https://510kreport.com/methodology