Cleared Traditional

K831689 - EMPTY DIALYSATE CONTAINER (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K831689 · Delmed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
79d
Days
Class 1
Risk

K831689 is an FDA 510(k) clearance for the EMPTY DIALYSATE CONTAINER. Classified as Clamp, Line (product code FKK), Class I - General Controls.

Submitted by Delmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 11, 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 876.4730 - 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 Delmed, Inc. devices

Submission Details

510(k) Number K831689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1983
Decision Date August 11, 1983
Days to Decision 79 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
51d faster than avg
Panel avg: 130d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FKK Clamp, Line
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.