Cleared Traditional

K933681 - GAMBRO LUNDIA PRO 100

K933681 is an FDA 510(k) clearance for GAMBRO LUNDIA PRO 100, manufactured by Cobe Renal Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJG cleared through the Traditional 510(k) pathway after a 405-day FDA review.

K933681 · Cobe Renal Care, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
405d
Days
Class 2
Risk

K933681 is an FDA 510(k) clearance for the GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS. Classified as Dialyzer, Parallel Flow (product code FJG), Class II - Special Controls.

Submitted by Cobe Renal Care, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 7, 1994 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Cobe Renal Care, Inc. devices

FDA 510(k) Submission Details - K933681

510(k) Number K933681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date September 07, 1994
Days to Decision 405 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
275d slower than avg
Panel avg: 130d · This submission: 405d
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 24
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K933681.
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
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