Cleared Traditional

K130460 - NXSTAGE DOSING CALCULATOR

K130460 is an FDA 510(k) clearance for NXSTAGE DOSING CALCULATOR, manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKP cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K130460 · Nxstage Medical, Inc. · Gastroenterology & Urology device
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Jul 2013
Decision
139d
Days
Class 2
Risk

K130460 is an FDA 510(k) clearance for the NXSTAGE DOSING CALCULATOR. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on July 11, 2013 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Nxstage Medical, Inc. devices

FDA 510(k) Submission Details - K130460

510(k) Number K130460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2013
Decision Date July 11, 2013
Days to Decision 139 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
9d slower than avg
Panel avg: 130d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKP Device Classification - Class 2, Special Controls

Product Code FKP System, Dialysate Delivery, Single Patient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FKP System, Dialysate Delivery, Single Patient

All 36
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K130460.
NxStage Connected Health System
K181991 · Nxstage Medical, Inc. · Sep 2018
NXSTAGE CONNECTED HEALTH SYSTEM
K131739 · Nxstage Medical, Inc. · Oct 2013
ONEVIEW INTERFACE
K040074 · Nxstage Medical, Inc. · Apr 2004
FRESENIUS ICARE MONITORING SYSTEM
K021060 · Fresenius Medical Care North America · Nov 2002
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955423 · Fresenius USA, Inc. · Jun 1996
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE
K930181 · Fresenius USA, Inc. · Nov 1995