# K190663: Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Jun 17, 2019 after 94 days
- Product code: BSN (Filter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5130
- 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 K083451 (2009). 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)
- K083451: Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays, Smiths Medical Asd, Inc. (2009) Summary page 5.

## Indications for use
The Pajunk Epidural MiniFilter NRFit (ISO80369-6) and Epidural MiniFilter LUER (ISO80369-7) is an anesthesia conduction filter. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. The anaesthesia conduction filter is intended for use for patients that weigh 10kg and above.

Source page: https://510kreport.com/device/K190663
Methodology: https://510kreport.com/methodology