# K122661: Vital 5 Releaf Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vital 5
- Decided: Feb 27, 2013 after 180 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: 1 generation back to K993592 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993592: Axiom Multipurpose Wound Drain, Axiom Medical, Inc. (2000) Summary page 1.

## Indications for use
ReLeaf catheters are indicated for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.

Source page: https://510kreport.com/device/K122661
Methodology: https://510kreport.com/methodology