# K063234: ON-Q Introducers

- Pathway: 510(k) (Abbreviated)
- Applicant: I-Flow Corp.
- Decided: Nov 21, 2006 after 27 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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 no predicate by number.

## Most influential descendants
- K102460: Ambit Introducer, Ambit Needle, Ambit Sheath (2011), 2 descendants of its own
- K200624: Percutaneous Introducer (2020), 0 descendants of its own
- K171584: B. Braun Tear-Away Introducer Needle (2017), 0 descendants of its own
- K110814: Ambit Tunneler (2011), 0 descendants of its own
- K102594: IO-Flex Catheter (2011), 0 descendants of its own

## Indications for use
The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.

Source page: https://510kreport.com/device/K063234
Methodology: https://510kreport.com/methodology