Cleared Traditional

K902149 - FRESENIUS/DELMED 90/2 PERITONEAL DIALYS...

K902149 is an FDA 510(k) clearance for FRESENIUS/DELMED 90/2 PERITONEAL DIALYS..., manufactured by Fresenius/Delmed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K902149 · Fresenius/Delmed, Inc. · Gastroenterology & Urology device
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Oct 1990
Decision
168d
Days
Class 2
Risk

K902149 is an FDA 510(k) clearance for the FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Fresenius/Delmed, Inc. (Concord, US). The FDA issued a Cleared decision on October 30, 1990 after a review of 168 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 Fresenius/Delmed, Inc. devices

FDA 510(k) Submission Details - K902149

510(k) Number K902149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1990
Decision Date October 30, 1990
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 130d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

Product Code FKX System, Peritoneal, Automatic Delivery
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 - FKX System, Peritoneal, Automatic Delivery

All 61
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K902149.
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
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R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
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NMC CYCLER MACHINE
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DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
K901477 · Delmed, Inc. · Jul 1990
DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
K901478 · Delmed, Inc. · Jul 1990
ABBOTT INPERSOL CYCLER 1000
K895336 · Abbott Laboratories · Nov 1989