# K991543: Intraop Catheter

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Oct 25, 1999 after 175 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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 K813186 (1981). 2 ancestors in all.
31 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840202: Epidural Catheter, Aries Medical, Inc. (1984) Summary page 1.
- K813186: Perfix Set for Epidural Anesthesia W/Tuo, Burron Medical Products, Inc. (1981) Summary page 1.
- (no number) Epimed Internation FETH-R_KATH catheter: named in the summary without a submission number

## Most influential descendants
- K994374: Soaker Catheter (2000), 18 descendants of its own
- K022869: Soaker Catheter (2002), 12 descendants of its own
- K043456: Modification to Soaker Catheter (2005), 11 descendants of its own
- K030830: B. Braun Nerve Block Catheter (2003), 10 descendants of its own
- K042488: Perifix Catheter and Contiplex Catheter (2004), 9 descendants of its own

## Indications for use
The Intra Op Catheter is intended to provide continuous or intermittent delivery of local anasthetics or narcotics to surgical wound sites and nerve trunks outside of the epidural space. Routes of administration may be either, intraoperative, intramuscular, subcutaneous or percutaneous.

Source page: https://510kreport.com/device/K991543
Methodology: https://510kreport.com/methodology