Cleared Traditional

K853255 - OMNIMED I.V. SOLUTION ADMIN. SET

K853255 is an FDA 510(k) clearance for OMNIMED I.V. SOLUTION ADMIN. SET, manufactured by Omni Intl., Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K853255 · Omni Intl., Inc. · General Hospital
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Aug 1985
Decision
21d
Days
Class 2
Risk

K853255 is an FDA 510(k) clearance for the OMNIMED I.V. SOLUTION ADMIN. SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Omni Intl., Inc. (Palm Springs, US). The FDA issued a Cleared decision on August 23, 1985 after a review of 21 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 Omni Intl., Inc. devices

FDA 510(k) Submission Details - K853255

510(k) Number K853255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1985
Decision Date August 23, 1985
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 659
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K853255.
CHURCHILL-H VENTED IV SET
K854437 · Churchill Corp. · Dec 1985
HUBOUT
K853287 · I M, Inc. · Oct 1985
CHURCHILL VENTED IV SET
K853204 · Churchill Corp. · Sep 1985
CONTROLLED RELEASE INFUSION SYSTEM(CRIS)
K852488 · Y · Jun 1985
NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)
K852140 · North American Instrument Corp. · May 1985
CORRECT FLO
K851299 · Norton Performance Plastics Corp. · May 1985