# K152952: E-Cath

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Jul 13, 2016 after 281 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.
1 later device descends from it; 1 cites it directly.
0 of 11 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 5.

## Most influential descendants
- K202699: E-Cath STIM acc. Tsui (2020), 0 descendants of its own

## Indications for use
The Over-the-needle (OTN) Catheter System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The Over-the-needle (OTN) Catheter System is contraindicated for the epidural space.

Source page: https://510kreport.com/device/K152952
Methodology: https://510kreport.com/methodology