Cleared Traditional

K011221 - PRISMA HF 1000 SET

K011221 is an FDA 510(k) clearance for PRISMA HF 1000 SET, manufactured by Gambro Renal Products. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K011221 · Gambro Renal Products · Gastroenterology & Urology device
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Oct 2001
Decision
194d
Days
Class 2
Risk

K011221 is an FDA 510(k) clearance for the PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on October 31, 2001 after a review of 194 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Gambro Renal Products devices

FDA 510(k) Submission Details - K011221

510(k) Number K011221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2001
Decision Date October 31, 2001
Days to Decision 194 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 130d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K011221.
NXSTAGE THERAPY SYSTEM
K020858 · Nxstage Medical, Inc. · Apr 2002
LIFEMATE MLA MULTI-LINE ADAPTOR
K011269 · Nxstage Medical, Inc. · Mar 2002
CLIRANS E-SERIES DIALYZER
K013550 · Terumo Medical Corp. · Nov 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · Nxstage Medical, Inc. · Oct 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · Baxter Healthcare Corp · Feb 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · Terumo Medical Corp. · Feb 2001