Cleared Traditional

K810315 - ALTERNATE STERILIZ. FOR CELLULOSE ACET

K810315 is an FDA 510(k) clearance for ALTERNATE STERILIZ. FOR CELLULOSE ACET, manufactured by Cordis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FKQ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K810315 · Cordis Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
43d
Days
Class 2
Risk

K810315 is an FDA 510(k) clearance for the ALTERNATE STERILIZ. FOR CELLULOSE ACET. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Cordis Corp. (Walker, US). The FDA issued a Cleared decision on March 20, 1981 after a review of 43 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 Cordis Corp. devices

FDA 510(k) Submission Details - K810315

510(k) Number K810315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1981
Decision Date March 20, 1981
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
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 K810315.
DISSCAP 140
K820965 · Hospal Medical Corp. · Apr 1982
DISSCAP 110
K820966 · Hospal Medical Corp. · Apr 1982
MODEL DM-333 DIALYSIS CONTROL STATION
K811444 · Extracorporeal Medical Specialities, Inc. · Jun 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
DIALYZING FLUIDE DELIVERY SYSTEM
K780081 · Travenol Laboratories, S.A. · Mar 1978