Cleared Traditional

K935274 - DIPRIVAN LUER CONNECTOR (FDA 510(k) Clearance)

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

K935274 · Ohmeda Medical · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
132d
Days
Class 2
Risk

K935274 is an FDA 510(k) clearance for the DIPRIVAN LUER CONNECTOR. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Ohmeda Medical (Tampa, US). The FDA issued a Cleared decision on March 15, 1994 after a review of 132 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Ohmeda Medical devices

Submission Details

510(k) Number K935274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1993
Decision Date March 15, 1994
Days to Decision 132 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 128d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 204
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