Cleared Traditional

K852309 - ERIKA ART LI

K852309 is an FDA 510(k) clearance for ERIKA ART LI, manufactured by Erika, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K852309 · Erika, Inc. · Gastroenterology & Urology device
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Jul 1985
Decision
58d
Days
Class 2
Risk

K852309 is an FDA 510(k) clearance for the ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Erika, Inc. (Rockleigh, US). The FDA issued a Cleared decision on July 26, 1985 after a review of 58 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 - K852309

510(k) Number K852309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date July 26, 1985
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJK Device Classification - Class 2, Special Controls

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 46
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K852309.
ERIKA ARTERIAL LINE 03-9625-9
K860740 · National Medical Care, Medical Products Div., Inc. · Mar 1986
ASA BLOOD TUBING LINES
K854271 · Organon Teknika Corp. · Nov 1985
ERIKA ARTERIAL LINE 03-9837-0
K853962 · National Medical Care, Medical Products Div., Inc. · Oct 1985
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
K831424 · Extracorporeal Medical Specialities, Inc. · Oct 1983
BLOOD LINE SETS FOR HEMOFILTRATION
K830677 · Gambro, Inc. · Apr 1983
TS-180 SERIES TUBING SET
K821138 · Extracorporeal Medical Specialities, Inc. · May 1982