Cleared Traditional

K904217 - PRO-LOK (TM) EXTENSION SETS

K904217 is an FDA 510(k) clearance for PRO-LOK (TM) EXTENSION SETS, manufactured by Vlv Associates, 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.

K904217 · Vlv Associates, Inc. · General Hospital
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Oct 1990
Decision
21d
Days
Class 2
Risk

K904217 is an FDA 510(k) clearance for the PRO-LOK (TM) EXTENSION SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Vlv Associates, Inc. (East Hanover, US). The FDA issued a Cleared decision on October 3, 1990 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.

FDA 510(k) Submission Details - K904217

510(k) Number K904217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date October 03, 1990
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 984
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K904217.
LOW VOLUME BIFURCATED IV EXTENSION SET
K901088 · Marquette Medical, Inc. · Oct 1990
LOW VOLUME TRIFURCATED IV EXTENSION SET
K901089 · Marquette Medical, Inc. · Oct 1990
PROTECTED NEEDLE WITH OR WITHOUT IV SET
K903809 · Kendall Mcgaw Laboratories, Inc. · Oct 1990
SPIVE NEEDLE SYSTEM, MODIFICATION
K904013 · Pascall Medical Corp. · Oct 1990
E-Z FLO + SET
K902330 · Prn Services, Inc. · Sep 1990
SAFETY INJECTION PORT
K903541 · Du-Call Miller Plastics, Inc. · Sep 1990
K904217 · PRO-LOK (TM) EXTENSION SETS
Download PDF Vlv Associates, Inc.