Cleared Traditional

MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A (K231849) - FDA 510(k) Clearance

Also marketed or referenced as:
MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483

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

K231849 · Baxter Healthcare · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
263d
Days
Class 2
Risk

K231849 is an FDA 510(k) clearance for the MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Baxter Healthcare (Round Lake, US). The FDA issued a Cleared decision on March 12, 2024 after a review of 263 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 Baxter Healthcare devices

Submission Details

510(k) Number K231849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2023
Decision Date March 12, 2024
Days to Decision 263 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 130d · This submission: 263d
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 37
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K231849.
stay•safe® catheter extension set with Safe- Lock, 12 inch
K250404 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2025
15L Cycler Drainage Bag
K214016 · Baxter Healthcare Corporation · Mar 2022
MiniCap Extended Life PD Transfer Sets
K192705 · Baxter Healthcare · Oct 2019
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