Cleared Traditional

K843623 - UNILYTE A

K843623 is the FDA 510(k) clearance for UNILYTE A by Medical Enterprises, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FKQ) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K843623 · Medical Enterprises, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
87d
Days
Class 2
Risk

K843623 is an FDA 510(k) clearance for the UNILYTE A. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Medical Enterprises, Ltd. (Jackson, US). The FDA issued a Cleared decision on November 16, 1984 after a review of 87 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 Medical Enterprises, Ltd. devices

Submission Details

510(k) Number K843623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1984
Decision Date November 16, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
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 32
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K843623.
NEPHROSS ALLEGRO H.F.
K844748 · Organon Teknika Corp. · Jan 1985
ST FAMILY OF HOLLOW FIBER DIALYZERS
K844756 · Travenol Laboratories, S.A. · Jan 1985
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
K843963 · Renal Systems, Inc. · Jan 1985
PACKETS FOR THE PREP OF DIALYSATES &
K842154 · Organon Teknika Corp. · Jul 1984
CONCENTRATE CONDUCTIVITY METER
K841543 · Renal Systems, Inc. · May 1984
RENAPAK CONCENTRATE MIXING SYS.
K840182 · Renal Systems, Inc. · May 1984