Cleared Traditional

K940258 - SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY) (FDA 510(k) Clearance)

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

K940258 · Incutech, Inc. · General Hospital
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Mar 1994
Decision
66d
Days
Class 2
Risk

K940258 is an FDA 510(k) clearance for the SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY). Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Incutech, Inc. (Greensboro, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - 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: 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 Incutech, Inc. devices

Submission Details

510(k) Number K940258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date March 28, 1994
Days to Decision 66 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
62d faster than avg
Panel avg: 128d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 - KPE Container, I.v.

All 116
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