Cleared Traditional

K830908 - BICARBONATE/VARIABLE SODIUM KIT-DM-367

K830908 is the FDA 510(k) clearance for BICARBONATE/VARIABLE SODIUM KIT-DM-367 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 79-day FDA review.

K830908 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Jun 1983
Decision
79d
Days
Class 2
Risk

K830908 is an FDA 510(k) clearance for the BICARBONATE/VARIABLE SODIUM KIT-DM-367. 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 8, 1983 after a review of 79 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 K830908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date June 08, 1983
Days to Decision 79 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
51d faster than avg
Panel avg: 130d · This submission: 79d
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 K830908.
PACKETS FOR THE PREP OF DIALYSATES &
K842154 · Organon Teknika Corp. · Jul 1984
GAMMA STERIL. CAPILLARY FLOW DIALY-G15
K832663 · Travenol Laboratories, S.A. · Sep 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K831940 · Travenol Laboratories, S.A. · Aug 1983
HEMAFLO BLOOD TUBING SETS
K823092 · Cobe Laboratories, Inc. · Nov 1982
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
K820769 · Gambro, Inc. · Apr 1982
MODEL DM-333 DIALYSIS CONTROL STATION
K811444 · Extracorporeal Medical Specialities, Inc. · Jun 1981