Cleared Traditional

K821367 - GF-180-M & GF-180-H HEMODIALYZERS

K821367 is an FDA 510(k) clearance for GF-180-M & GF-180-H HEMODIALYZERS, 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 18-day FDA review.

K821367 · Gambro, Inc. · Gastroenterology & Urology device
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May 1982
Decision
18d
Days
Class 2
Risk

K821367 is an FDA 510(k) clearance for the GF-180-M & GF-180-H HEMODIALYZERS. 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 May 28, 1982 after a review of 18 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 - K821367

510(k) Number K821367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1982
Decision Date May 28, 1982
Days to Decision 18 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
112d faster than avg
Panel avg: 130d · This submission: 18d
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 K821367.
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
K822049 · Gambro, Inc. · Aug 1982
ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE
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ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN
K822226 · Erika, Inc. · Aug 1982
DISPOSABLE BLOOD LINE CONNECTORS
K821495 · Bentley Laboratories, Inc. · May 1982
CLIRANS TE12 HOLLOW FIBER DIALYZER
K812498 · Terumo Medical Corp. · Sep 1981
ISOLATER THP
K811981 · Tri-Med, Inc. · Aug 1981