# K193664: SubQKath Catheter and Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Hk Surgical
- Decided: Sep 9, 2020 after 253 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: 8 generations back to K813186 (1981). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111031: Painfusor Catheter, Plan 1 Health, S.R.L. (2011) Summary page 4.

## Indications for use
The SubQKath Catheter and Needle Kit is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with surgical procedures.

Source page: https://510kreport.com/device/K193664
Methodology: https://510kreport.com/methodology