Cleared Traditional

K822485 - HPF 100

K822485 is an FDA 510(k) clearance for HPF 100, manufactured by Erika, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKQ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K822485 · Erika, Inc. · Gastroenterology & Urology device
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Aug 1982
Decision
13d
Days
Class 2
Risk

K822485 is an FDA 510(k) clearance for the HPF 100,200,300 CAPILLARY FLOW DIALYZ. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Erika, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1982 after a review of 13 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 - K822485

510(k) Number K822485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1982
Decision Date August 30, 1982
Days to Decision 13 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
117d faster than avg
Panel avg: 130d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKQ Device Classification - Class 2, Special Controls

Product Code FKQ System, Dialysate Delivery, Central Multiple Patient
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 - FKQ System, Dialysate Delivery, Central Multiple Patient

All 31
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K822485.
HEMAFLO BLOOD TUBING SETS
K823092 · Cobe Laboratories, Inc. · Nov 1982
DISSCAP 080
K822851 · Hospal Medical Corp. · Oct 1982
CIDEX*DIALYZER DISINFECTING SOLUTION
K822535 · Surgikos, Inc. · Sep 1982
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
K820769 · Gambro, Inc. · Apr 1982
DISSCAP 140
K820965 · Hospal Medical Corp. · Apr 1982
DISSCAP 110
K820966 · Hospal Medical Corp. · Apr 1982