Cleared Traditional

K983411 - COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105

K983411 is an FDA 510(k) clearance for COLORVEES IV SET 20 DROPS/ML 105, manufactured by Valnet Medical Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K983411 · Valnet Medical Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
134d
Days
Class 2
Risk

K983411 is an FDA 510(k) clearance for the COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTE.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Valnet Medical Corp. (Santa Isabel, US). The FDA issued a Cleared decision on February 9, 1999 after a review of 134 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 Valnet Medical Corp. devices

FDA 510(k) Submission Details - K983411

510(k) Number K983411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1998
Decision Date February 09, 1999
Days to Decision 134 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 129d · This submission: 134d
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 772
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K983411.
KVO CHECK VALVE ACCESSORY, MODEL EV-0001
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