Cleared Traditional

K955423 - PACK H HEMODIALYSIS UREA KINETIC MODELI...

K955423 is an FDA 510(k) clearance for PACK H HEMODIALYSIS UREA KINETIC MODELI..., manufactured by Fresenius USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKP cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K955423 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 1996
Decision
198d
Days
Class 2
Risk

K955423 is an FDA 510(k) clearance for the PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 198 days - an extended review 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: 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 Fresenius USA, Inc. devices

FDA 510(k) Submission Details - K955423

510(k) Number K955423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1995
Decision Date June 13, 1996
Days to Decision 198 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 130d · This submission: 198d
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
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