# K121525: Perifuse Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Aug 2, 2012 after 71 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K813186 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001129: Prolong, Models PL50, PL100, PL150, Life-Tech Intl., Inc. (2000) Summary page 1.
- K994275: Sims Portex Anesthesia Catheter, Sims Portex, Inc. (2000) Summary page 1.

## Indications for use
The PeriFuseTM regional anesthesia Catheter is indicated for use during procedures where intermittent administration of local anesthetics is indicated for control of operative, post-operative, acute or chronic pain for peripheral nerve block procedures. The duration of use should not exceed 72 hours.

Source page: https://510kreport.com/device/K121525
Methodology: https://510kreport.com/methodology