Cleared Traditional

K823791 - LUNDIA 10-5-L PARRALLE FLOW DIALYZER

K823791 is an FDA 510(k) clearance for LUNDIA 10-5-L PARRALLE 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 27-day FDA review.

K823791 · Gambro, Inc. · Gastroenterology & Urology device
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Jan 1983
Decision
27d
Days
Class 2
Risk

K823791 is an FDA 510(k) clearance for the LUNDIA 10-5-L PARRALLE 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 January 12, 1983 after a review of 27 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 - K823791

510(k) Number K823791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1982
Decision Date January 12, 1983
Days to Decision 27 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
103d faster than avg
Panel avg: 130d · This submission: 27d
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 K823791.
KF-101-10 DIALYZER
K822338 · Extracorporeal Medical Specialities, Inc. · Feb 1983
KF-101-13 DIALYZER
K822339 · Extracorporeal Medical Specialities, Inc. · Feb 1983
A.V. FISTULA CANNULATION SETS
K830021 · Travenol Laboratories, S.A. · Jan 1983
CAPILLARY FLOW DIALYZERS
K823826 · Travenol Laboratories, S.A. · Jan 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K823778 · Travenol Laboratories, S.A. · Jan 1983
HOSPAL BLOOD LINES
K823707 · Hospal Medical Corp. · Jan 1983