Not Cleared Traditional

CORFLO 300 PUMP (K944750) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944750 · Corpak, Inc. · General Hospital
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Jun 1995
Decision
266d
Days
Class 2
Risk

K944750 is an FDA 510(k) submission (not cleared) for the CORFLO 300 PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Corpak, Inc. (Wheeling, US). The FDA issued a Not Cleared (DENG) decision on June 19, 1995 after a review of 266 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 266 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Corpak, Inc. devices

Submission Details

510(k) Number K944750 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received September 26, 1994
Decision Date June 19, 1995
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 847
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