Cleared Traditional

K022913 - NXSTAGE PREMIXED DIALYSATE

K022913 is an FDA 510(k) clearance for NXSTAGE PREMIXED DIALYSATE, manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K022913 · Nxstage Medical, Inc. · Gastroenterology & Urology device
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Oct 2002
Decision
48d
Days
Class 2
Risk

K022913 is an FDA 510(k) clearance for the NXSTAGE PREMIXED DIALYSATE. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on October 21, 2002 after a review of 48 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nxstage Medical, Inc. devices

FDA 510(k) Submission Details - K022913

510(k) Number K022913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date October 21, 2002
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 130d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KPO Device Classification - Class 2, Special Controls

Product Code KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)
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 Consultant

Intertek Testing Services
DONALD JAMES SHERRATT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 59
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K022913.
NXSTAGE PUREFLOW-B SOLUTION
K042045 · Nxstage Medical, Inc. · Aug 2004
B.BRAUN PREMIXED DIALYSATE
K034066 · B.Braun Medical, Inc. · Mar 2004
NXSTAGE PUREFLOW SOLUTION
K033386 · Nxstage Medical, Inc. · Nov 2003
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · Nxstage Medical, Inc. · Feb 2002
PRISMASATE
K013448 · Gambro Renal Products · Jan 2002
BICART
K013724 · Gambro Renal Products · Jan 2002

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.