Cleared Traditional

K864835 - TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* (FDA 510(k) Clearance)

Class I Radiology device.

K864835 · Eisai U.S.A., Inc. · Radiology device
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Feb 1987
Decision
64d
Days
Class 1
Risk

K864835 is an FDA 510(k) clearance for the TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*. Classified as Barium Enema Kit (product code FCD), Class I - General Controls.

Submitted by Eisai U.S.A., Inc. (Torrance, US). The FDA issued a Cleared decision on February 11, 1987 after a review of 64 days - a notably fast clearance cycle.

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: 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 Eisai U.S.A., Inc. devices

Submission Details

510(k) Number K864835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date February 11, 1987
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCD Barium 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.