# K151620: Firefly Peritoneal Dialysis Connector Disinfection System

- Pathway: 510(k) (Traditional)
- Applicant: Puracath Medical, Inc.
- Decided: Jan 20, 2016 after 218 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- 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 K030467 (2003). 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)
- K883239: Capd Ultraviolet (U.V.) Germicidal Exchange Dev Sys, Baxter Healthcare Corp (1988) Summary page 5.
- K142806: DualCap, Catheter Connections, Inc. (2015) Summary page 6.

## Indications for use
The PuraCath™ Firefly™ Peritoneal Dialysis Connector Disinfecting System is intended for use by PD (peritoneal dialysis) patients as a method of controlling air and touch contamination while performing a solution exchange. The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System is comprised of Firefly™ UV Purification Device, Firefly™ Transfer Catheter, Firefly™ Luer Cover, and Firefly™ 99% IPA bottle. The effectiveness of the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Streptococcus pneumoniae, Methicillin-resistant Staphylococcus aureus, and Candida albicans yielding > 4log reduction in micro-organisms. The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthcare facility.

Source page: https://510kreport.com/device/K151620
Methodology: https://510kreport.com/methodology