Cleared Traditional

K811444 - MODEL DM-333 DIALYSIS CONTROL STATION

K811444 is the FDA 510(k) clearance for MODEL DM-333 DIALYSIS CONTROL STATION by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKQ) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K811444 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Jun 1981
Decision
32d
Days
Class 2
Risk

K811444 is an FDA 510(k) clearance for the MODEL DM-333 DIALYSIS CONTROL STATION. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 23, 1981 after a review of 32 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 Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K811444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1981
Decision Date June 23, 1981
Days to Decision 32 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
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K811444.
BICARBONATE/VARIABLE SODIUM KIT-DM-367
K830908 · Extracorporeal Medical Specialities, Inc. · Jun 1983
HEMAFLO BLOOD TUBING SETS
K823092 · Cobe Laboratories, Inc. · Nov 1982
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
K820769 · Gambro, Inc. · Apr 1982
ALTERNATE STERILIZ. FOR CELLULOSE ACET
K810315 · Cordis Corp. · Mar 1981
MOD. DM-356 IPS INTERFACE MODULE
K800771 · Extracorporeal Medical Specialities, Inc. · May 1980
PATIENT AID, MODEL DM-351
K781176 · Extracorporeal Medical Specialities, Inc. · Sep 1978