Cleared Traditional

K791322 - ERIKA HPF 300

K791322 is an FDA 510(k) clearance for ERIKA HPF 300, manufactured by Erika, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K791322 · Erika, Inc. · Gastroenterology & Urology device
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Sep 1979
Decision
74d
Days
Class 2
Risk

K791322 is an FDA 510(k) clearance for the ERIKA HPF 300. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Erika, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1979 after a review of 74 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 - K791322

510(k) Number K791322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1979
Decision Date September 24, 1979
Days to Decision 74 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
56d faster than avg
Panel avg: 130d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

Product Code FJI Dialyzer, Capillary, Hollow Fiber
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 97
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K791322.
C-DAK 2100 ARTIFICIAL KIDNEY
K792419 · Cordis Corp. · Jan 1980
ERIKA HPF 100
K791320 · Erika, Inc. · Sep 1979
ERIKA HPF 200
K791321 · Erika, Inc. · Sep 1979
DISPOSABLE DIALYZERS, SD-ID, SD-2D
K790308 · Bentley Laboratories, Inc. · May 1979
FLOW DIALYZER, CF 2300 CAPILLARY
K790067 · Travenol Laboratories, S.A. · Apr 1979
ARTIFICIAL KIDNEY, C-DAK 0.6D
K782151 · Cordis Corp. · Feb 1979