Cleared Traditional

K850051 - VERSA-FILL 120 & FILL SET 42-50

K850051 is an FDA 510(k) clearance for VERSA-FILL 120 & FILL SET 42-50, manufactured by Intl. Medical Industries. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K850051 · Intl. Medical Industries · General Hospital
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Mar 1985
Decision
57d
Days
Class 2
Risk

K850051 is an FDA 510(k) clearance for the VERSA-FILL 120 & FILL SET 42-50. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Intl. Medical Industries (Watertown, US). The FDA issued a Cleared decision on March 6, 1985 after a review of 57 days - a notably fast clearance cycle.

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: 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 Intl. Medical Industries devices

FDA 510(k) Submission Details - K850051

510(k) Number K850051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date March 06, 1985
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

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 156
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K850051.
FLOW EASE(PLASTIC VENTED NEEDLE)
K853212 · Acacia, Inc. · Sep 1985
TRANSFER DEVICE
K853188 · Advance Medical Designs, Inc. · Aug 1985
TANDEM SETS I.V.
K850757 · Acacia, Inc. · Apr 1985
TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP
K844340 · Travenol Laboratories, S.A. · Jan 1985
ACKRAD FLUID CONNECTING SET
K820937 · Ackrad Laboratories · Apr 1982
VACU-FIL TRANSFER SET
K812928 · American Pharmaseal Div. Ahsc · Dec 1981