Cleared Traditional

ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF (K833252) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833252 · Erika, Inc. · Gastroenterology & Urology device

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Dec 1983

Decision

85d

Days

Class 2

Risk

K833252 is an FDA 510(k) clearance for the ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF. 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 December 14, 1983 after a review of 85 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

Submission Details

510(k) Number	K833252 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 20, 1983
Decision Date	December 14, 1983
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

45d faster than avg

Panel avg: 130d · This submission: 85d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 37

Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K833252.

HOLLOW FIBER DIALYZERS

K840845 · Travenol Laboratories, S.A. · Aug 1984

BSM 2000 DIALYSIS MACHINE

K840062 · Organon Teknika Corp. · Mar 1984

DUAL LUMEN NEEDLE

K833308 · Quinton, Inc. · Dec 1983

CLIRANS MODEL TAF 15 HOLLOW FIBER

K833503 · Terumo Medical Corp. · Dec 1983

NEPHROSS PRESTO

K832666 · Organon Teknika Corp. · Oct 1983

CLIRANS TAF06 HOLLOW FIBER DIALYZER

K832252 · Terumo Medical Corp. · Aug 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K833252

Erika, Inc.

Mchenry, IL · US

Regulatory profile

43 submissions 43 cleared

100% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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