Cleared Traditional

K822226 - ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN

K822226 is an FDA 510(k) clearance for ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN, manufactured by Erika, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K822226 · Erika, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1982
Decision
20d
Days
Class 2
Risk

K822226 is an FDA 510(k) clearance for the ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Erika, Inc. (Walker, US). The FDA issued a Cleared decision on August 16, 1982 after a review of 20 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 Erika, Inc. devices

FDA 510(k) Submission Details - K822226

510(k) Number K822226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1982
Decision Date August 16, 1982
Days to Decision 20 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
110d faster than avg
Panel avg: 130d · This submission: 20d
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 K822226.
TS-000 ARTERIOVENOUS BLOOD TUBING SET
K822283 · Extracorporeal Medical Specialities, Inc. · Aug 1982
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
K822049 · Gambro, Inc. · Aug 1982
ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE
K822225 · Erika, Inc. · Aug 1982
GF-180-M & GF-180-H HEMODIALYZERS
K821367 · Gambro, Inc. · May 1982
DISPOSABLE BLOOD LINE CONNECTORS
K821495 · Bentley Laboratories, Inc. · May 1982
CLIRANS TE12 HOLLOW FIBER DIALYZER
K812498 · Terumo Medical Corp. · Sep 1981