# K904883: OPTYX

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 24, 1991 after 271 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K121159: Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino Flex Adapter (2012), 2 descendants of its own
- K133754: Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Flex Adapter (2014), 0 descendants of its own
- K131184: Integra Licox PTO2 Monitor (2013), 0 descendants of its own
- K102802: Integra Electrode Tunneling Needle (2010), 0 descendants of its own

## Recalls of this device
- Mar 16, 2009 · Not classified · Z-2053-2009: Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip.

Source page: https://510kreport.com/device/K904883
Methodology: https://510kreport.com/methodology