Cleared Traditional

K902810 - STERILE I.V. START KIT

K902810 is the FDA 510(k) clearance for STERILE I.V. START KIT by Orion Life Systems, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K902810 · Orion Life Systems, Inc. · General Hospital
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Nov 1990
Decision
139d
Days
Class 2
Risk

K902810 is an FDA 510(k) clearance for the STERILE I.V. START KIT. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on November 13, 1990 after a review of 139 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 Orion Life Systems, Inc. devices

Submission Details

510(k) Number K902810 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received June 27, 1990
Decision Date November 13, 1990
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 279
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