Cleared Traditional

K924110 - LEOCOR CORFLO PUMP -- MODIFICATION

K924110 is an FDA 510(k) clearance for LEOCOR CORFLO PUMP -- MODIFICATION, manufactured by Leocor, Inc.. The device is a Class 2 General Hospital device with product code DQI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K924110 · Leocor, Inc. · General Hospital
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Sep 1992
Decision
90d
Days
Class 2
Risk

K924110 is an FDA 510(k) clearance for the LEOCOR CORFLO PUMP -- MODIFICATION. Classified as Withdrawal/infusion Pump (product code DQI), Class II - Special Controls.

Submitted by Leocor, Inc. (Houston, US). The FDA issued a Cleared decision on September 1, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1800 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Leocor, Inc. devices

FDA 510(k) Submission Details - K924110

510(k) Number K924110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1992
Decision Date September 01, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQI Device Classification - Class 2, Special Controls

Product Code DQI Withdrawal/infusion Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1800
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 General Hospital devices follow this clearance model.

Regulatory Peers - DQI Withdrawal/infusion Pump

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