Cleared Traditional

K810810 - AMICON ULTRAFILTRATION MEMBRANES CMII

K810810 is an FDA 510(k) clearance for AMICON ULTRAFILTRATION MEMBRANES CMII, manufactured by Amicon, Inc.. The device is a Class 2 Chemistry device with product code DHX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K810810 · Amicon, Inc. · Chemistry device

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Apr 1981

Decision

24d

Days

Class 2

Risk

K810810 is an FDA 510(k) clearance for the AMICON ULTRAFILTRATION MEMBRANES CMII. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Amicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.6010 - the FDA in vitro diagnostics and chemistry 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.

FDA 510(k) Submission Details - K810810

510(k) Number	K810810 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 24, 1981
Decision Date	April 17, 1981
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

65d faster than avg

Panel avg: 89d · This submission: 24d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

DHX Device Classification - Class 2, Special Controls

Product Code	DHX System, Test, Carcinoembryonic Antigen
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.6010

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 Chemistry devices follow this clearance model.

Regulatory Peers - DHX System, Test, Carcinoembryonic Antigen

All 27

Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K810810.

CEA CONTROL PLASMA

K812658 · Pacific Hemostasis · Sep 1981

THREE LEVEL CONTROL SERA

K810459 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1981

CEA DESALTING DOLUMN SEPHADEX R

K811394 · Immuno-Diagnostic Laboratories · Jun 1981

CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL

K792377 · Environmental Chemical Specialties · Sep 1980

CLINETICS PCA COLUMN

K801306 · Clinetics Corp. · Sep 1980

FDA 510(k) Resources - Chemistry

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

Manufacturer of K810810

Amicon, Inc.

Mchenry, IL · US

Regulatory profile

20 submissions 20 cleared

100% clearance rate · Active in Chemistry

View all devices by Amicon, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: April 17, 1981. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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