Cleared Traditional

K820769 - GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL

K820769 is an FDA 510(k) clearance for GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKQ cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K820769 · Gambro, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
25d
Days
Class 2
Risk

K820769 is an FDA 510(k) clearance for the GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1982 after a review of 25 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K820769

510(k) Number K820769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1982
Decision Date April 16, 1982
Days to Decision 25 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
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKQ Device Classification - Class 2, Special Controls

Product Code FKQ System, Dialysate Delivery, Central Multiple Patient
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 - FKQ System, Dialysate Delivery, Central Multiple Patient

All 31
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K820769.
DISSCAP 080
K822851 · Hospal Medical Corp. · Oct 1982
CIDEX*DIALYZER DISINFECTING SOLUTION
K822535 · Surgikos, Inc. · Sep 1982
HPF 100,200,300 CAPILLARY FLOW DIALYZ
K822485 · Erika, Inc. · Aug 1982
DISSCAP 140
K820965 · Hospal Medical Corp. · Apr 1982
DISSCAP 110
K820966 · Hospal Medical Corp. · Apr 1982
MODEL DM-333 DIALYSIS CONTROL STATION
K811444 · Extracorporeal Medical Specialities, Inc. · Jun 1981