Cleared Traditional

K842436 - ERIKA NEGATIVE PRESS. ARTERIAL BLOOD

K842436 is an FDA 510(k) clearance for ERIKA NEGATIVE PRESS. ARTERIAL BLOOD, 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 23-day FDA review.

K842436 · Erika, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
23d
Days
Class 2
Risk

K842436 is an FDA 510(k) clearance for the ERIKA NEGATIVE PRESS. ARTERIAL BLOOD. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Erika, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1984 after a review of 23 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 - K842436

510(k) Number K842436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1984
Decision Date July 13, 1984
Days to Decision 23 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
107d faster than avg
Panel avg: 130d · This submission: 23d
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 K842436.
HOLLOW FIBER DIALYZER
K843632 · Travenol Laboratories, S.A. · Oct 1984
CAPILLARY FLOW DIALYZERS
K840937 · Travenol Laboratories, S.A. · Sep 1984
HOLLOW FIBER DIALYZERS
K840845 · Travenol Laboratories, S.A. · Aug 1984
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER
K831173 · Erika, Inc. · Jun 1984
FILTRYZER HOLLOW FIBER ARTIFICIAL KID-
K831174 · Erika, Inc. · Jun 1984
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
K831175 · Erika, Inc. · Jun 1984