Cleared Traditional

K931896 - PRO-FLO SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K931896 · Lafayette Pharmacal, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
133d
Days
Class 1
Risk

K931896 is an FDA 510(k) clearance for the PRO-FLO SYSTEM. Classified as Enema Kit (product code FCE), Class I - General Controls.

Submitted by Lafayette Pharmacal, Inc. (Lafayette, US). The FDA issued a Cleared decision on August 26, 1993 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.5210 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lafayette Pharmacal, Inc. devices

Submission Details

510(k) Number K931896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1993
Decision Date August 26, 1993
Days to Decision 133 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 107d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCE Enema Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5210
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.this Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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.