Cleared Traditional

K853406 - GAMBRO LUNDIA PRO 3 & 5 DIALYZER

K853406 is an FDA 510(k) clearance for GAMBRO LUNDIA PRO 3 & 5 DIALYZER, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJG cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K853406 · Gambro, Inc. · Gastroenterology & Urology device
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Jan 1986
Decision
149d
Days
Class 2
Risk

K853406 is an FDA 510(k) clearance for the GAMBRO LUNDIA PRO 3 & 5 DIALYZER. Classified as Dialyzer, Parallel Flow (product code FJG), Class II - Special Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on January 8, 1986 after a review of 149 days - within the typical 510(k) review window.

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 Gambro, Inc. devices

FDA 510(k) Submission Details - K853406

510(k) Number K853406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date January 08, 1986
Days to Decision 149 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
19d slower than avg
Panel avg: 130d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJG Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K853406.
DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9
K920693 · National Medical Care, Medical Products Div., Inc. · Sep 1992
TENCKHOFF PERITONEAL DIALYSIS KIT
K902203 · Akcess Medical Products, Inc. · Aug 1990
GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
K862840 · Gambro, Inc. · Sep 1986
COBE PPD 1.3L, #18-520-009
K820694 · Cobe Laboratories, Inc. · Mar 1982
COBE PPD 1.9
K812336 · Cobe Laboratories, Inc. · Aug 1981
EXP 200 PARALLEL PLATE DIALYZER
K811439 · Extracorporeal Medical Specialities, Inc. · Jun 1981