Cleared Traditional

K822049 - LUNDIA 10-5 N PARALLEL FLOW DIALYZER

K822049 is an FDA 510(k) clearance for LUNDIA 10-5 N PARALLEL FLOW DIALYZER, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K822049 · Gambro, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1982
Decision
35d
Days
Class 2
Risk

K822049 is an FDA 510(k) clearance for the LUNDIA 10-5 N PARALLEL FLOW DIALYZER. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982 after a review of 35 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 - K822049

510(k) Number K822049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1982
Decision Date August 16, 1982
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 124
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K822049.
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K822796 · Erika, Inc. · Oct 1982
TRIEX-IH DIALYZER
K822738 · Extracorporeal Medical Specialities, Inc. · Sep 1982
TS-000 ARTERIOVENOUS BLOOD TUBING SET
K822283 · Extracorporeal Medical Specialities, Inc. · Aug 1982
ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE
K822225 · Erika, Inc. · Aug 1982
ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN
K822226 · Erika, Inc. · Aug 1982
GF-180-M & GF-180-H HEMODIALYZERS
K821367 · Gambro, Inc. · May 1982