# K181782: Medline Reinforced Epidural Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Mar 4, 2019 after 244 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: 3 generations back to K884552 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
3 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140110: Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set, Teleflex, Inc. (2015) Summary page 5.

## Indications for use
The Medline Reinforced Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for patients over 22lbs. (10kg), for a duration of use up to 72 hours.

Source page: https://510kreport.com/device/K181782
Methodology: https://510kreport.com/methodology