# K171193: Certa Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ferrosan Medical Devices Sp. Z.O.O.
- Decided: Dec 18, 2017 after 238 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: 6 generations back to K813186 (1981). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143164: ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set, Kimberly-Clark Corporation (2014) Summary page 4.

## Indications for use
Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in lower extremity blocks. It may be used by a qualified healthcare professional in a perioperative monitored care setting. Certa Catheter™ is intended for use in adult patients only. It should always be inserted and placed under ultrasound guidance by a healthcare professional. The Certa Catheter has not been evaluated for use in upper extremity blocks.

Source page: https://510kreport.com/device/K171193
Methodology: https://510kreport.com/methodology