Cleared Traditional

K812811 - MICROCOIL 80 DIALYZER

K812811 is an FDA 510(k) clearance for MICROCOIL 80 DIALYZER, manufactured by Erika, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FHS cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K812811 · Erika, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1981
Decision
58d
Days
Class 2
Risk

K812811 is an FDA 510(k) clearance for the MICROCOIL 80 DIALYZER. Classified as Dialyzer, Single Coil (product code FHS), Class II - Special Controls.

Submitted by Erika, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1981 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 - K812811

510(k) Number K812811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date December 03, 1981
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.

FHS Device Classification - Class 2, Special Controls

Product Code FHS Dialyzer, Single Coil
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 - FHS Dialyzer, Single Coil

All 10
Devices cleared under the same product code (FHS) and FDA review panel - the closest regulatory comparables to K812811.
MICROCOIL 150 DIALYZER
K811974 · Erika, Inc. · Sep 1981
MICRO-COIL 100 COIL DIALYZER
K800723 · Erika, Inc. · May 1980
GAMBRO LUNDIA COIL DIALYZER
K800174 · Gambro, Inc. · Feb 1980
DIALYZER, CD-800 COIL
K790223 · Travenol Laboratories, S.A. · Mar 1979
DIALYZER, DISP., COIL, LUNDIA
K781102 · Gambro, Inc. · Oct 1978
MODIFICATION TO KIDNEY DIALYZER
K771349 · Erika, Inc. · Aug 1977