Cleared Traditional

Firefly Peritoneal Dialysis Connector Disinfection System (K151620) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151620 · Puracath Medical, Inc. · Gastroenterology & Urology device
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Jan 2016
Decision
218d
Days
Class 2
Risk

K151620 is an FDA 510(k) clearance for the Firefly Peritoneal Dialysis Connector Disinfection System. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Puracath Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on January 20, 2016 after a review of 218 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Puracath Medical, Inc. devices

Submission Details

510(k) Number K151620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2015
Decision Date January 20, 2016
Days to Decision 218 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 130d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 38
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K151620.
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch
K173593 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
K173651 · Fresenius Medical Care Renal Therapies Group, LLC · Feb 2018
Cycler Drain Bag Set
K173363 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2018
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
K031676 · Baxter Healthcare Corp · Nov 2003
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
K972579 · Baxter Healthcare Corp · Oct 1997
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825 · Baxter Healthcare Corp · Aug 1996