Cleared Traditional

K854965 - IN LINE VALVE CATALOG NO. 2000A

K854965 is an FDA 510(k) clearance for IN LINE VALVE CATALOG NO. 2000A, manufactured by Rao Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K854965 · Rao Medical Devices, Inc. · General Hospital
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Feb 1986
Decision
72d
Days
Class 2
Risk

K854965 is an FDA 510(k) clearance for the IN LINE VALVE CATALOG NO. 2000A. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Rao Medical Devices, Inc. (Hudson, US). The FDA issued a Cleared decision on February 21, 1986 after a review of 72 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 Rao Medical Devices, Inc. devices

FDA 510(k) Submission Details - K854965

510(k) Number K854965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1985
Decision Date February 21, 1986
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
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 514
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K854965.
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SOLUTION ADMINISTRATION SET
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CHURCHILL - HBC VENTED BALL CHECK IV SET
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IVAC CONTROLLED RELEASE INFUSION SYSTEM
K854574 · Y · Jan 1986
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K854446 · Terumo Medical Corp. · Jan 1986