Cleared Traditional

K901478 - DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION

K901478 is an FDA 510(k) clearance for DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG ..., manufactured by Delmed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K901478 · Delmed, Inc. · Gastroenterology & Urology device
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Jul 1990
Decision
122d
Days
Class 2
Risk

K901478 is an FDA 510(k) clearance for the DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Delmed, Inc. (Concord, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 122 days - within the typical 510(k) review window.

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 Delmed, Inc. devices

FDA 510(k) Submission Details - K901478

510(k) Number K901478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1990
Decision Date July 27, 1990
Days to Decision 122 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 131d · This submission: 122d
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 60
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K901478.
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
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K905809 · National Medical Care, Medical Products Div., Inc. · Feb 1992
DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
K901477 · Delmed, Inc. · Jul 1990
ABBOTT INPERSOL CYCLER 1000
K895336 · Abbott Laboratories · Nov 1989
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
K884554 · Baxter Healthcare Corp · Jan 1989
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
K874632 · Quinton, Inc. · Dec 1987