# K102594: IO-Flex Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Baxano, Inc.
- Decided: Jan 19, 2011 after 132 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K896422 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063234: ON-Q Introducers, I-Flow Corp. (2006) Summary page 1.
- K042488: Perifix Catheter and Contiplex Catheter, B.Braun Medical, Inc. (2004) Summary page 1.
- K993592: Axiom Multipurpose Wound Drain, Axiom Medical, Inc. (2000) Summary page 1.

## Indications for use
The iO-Flex Catheter is for continuous or intermittent preoperative, perioperative or post-operative delivery of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management. The catheter may also be used perioperatively during open spinal procedures to irrigate, aspirate or inject a bolus of fluid or medication. The iO-Flex Catheter is designed for use with the iO-Flex Wire.

Source page: https://510kreport.com/device/K102594
Methodology: https://510kreport.com/methodology