Cleared Traditional

K915504 - GAMBRO LUNDIA ALPHA HEMODIALYZERS

K915504 is the FDA 510(k) clearance for GAMBRO LUNDIA ALPHA HEMODIALYZERS by C.G.H. Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJG) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K915504 · C.G.H. Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
88d
Days
Class 2
Risk

K915504 is an FDA 510(k) clearance for the GAMBRO LUNDIA ALPHA HEMODIALYZERS. Classified as Dialyzer, Parallel Flow (product code FJG), Class II - Special Controls.

Submitted by C.G.H. Medical, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 6, 1992 after a review of 88 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 C.G.H. Medical, Inc. devices

Submission Details

510(k) Number K915504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date March 06, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJG Dialyzer, Parallel Flow
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 - FJG Dialyzer, Parallel Flow

All 13
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K915504.
GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
K862840 · Gambro, Inc. · Sep 1986
GAMBRO LUNDIA PRO 3 & 5 DIALYZER
K853406 · Gambro, Inc. · Jan 1986
COBE PPD 1.3L, #18-520-009
K820694 · Cobe Laboratories, Inc. · Mar 1982
COBE PPD 1.9
K812336 · Cobe Laboratories, Inc. · Aug 1981
COBE PPD .8
K810066 · Cobe Laboratories, Inc. · Jun 1981
GAMBRO LUNDIA PLATE DISP. DIALYZER
K802389 · Gambro, Inc. · Dec 1980