# K053283: Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set

- Pathway: 510(k) (Special)
- Applicant: Pajunk GmbH
- Decided: Jan 12, 2006 after 48 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: 4 generations back to K840287 (1984). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000722: Unipolar Needles, Pajunk GmbH (2000) Summary page 1.
- K023218: Modification to Plexolong Sets, Pajunk GmbH (2003) Summary page 1.
- K033018: Stimulong Plus Catheter Set Model, Various, Pajunk GmbH (2004) Summary page 1.
- K013041: Plexolong Sets, Pajunk GmbH (2002) Summary page 1.
- K042979: Modification to: Plexalong Sets, Pajunk GmbH (2004) Summary page 1.
- K994059: Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07, Hdc Corp. (2000) Summary page 1.

## Most influential descendants
- K173110: Graftsite (2018), 0 descendants of its own
- K082164: Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus: Single Shot (2008), 0 descendants of its own

## Indications for use
The change of coating material from lacqueur to Parylene does not affect the Indications for use of the predicated devices marketed under K042979 (Pajunk Plexolong Sets) K033018 (Pajunk Stimulong Plus Catheter Sets) K023218 (Pajunk Plexolong Sets) K013041 (Pajunk Plexolong Anesthesia Sets) K000722 (Unipolar Needles with Standard and Sprotte-tip) The change in coating has no effect on the Indications for use of these devices already cleared for market.

Source page: https://510kreport.com/device/K053283
Methodology: https://510kreport.com/methodology