Cleared Traditional

K922469 - PRO-LOK EXTENSION SET(S)

K922469 is an FDA 510(k) clearance for PRO-LOK EXTENSION SET(S), 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 293-day FDA review.

K922469 · Vlv Associates, Inc. · General Hospital
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Mar 1993
Decision
293d
Days
Class 2
Risk

K922469 is an FDA 510(k) clearance for the PRO-LOK EXTENSION SET(S). 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 March 15, 1993 after a review of 293 days - an extended review 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: 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 Vlv Associates, Inc. devices

FDA 510(k) Submission Details - K922469

510(k) Number K922469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1992
Decision Date March 15, 1993
Days to Decision 293 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 129d · This submission: 293d
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 646
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K922469.
INTERLINK(TM) INJECTION SITE
K925126 · Baxter Healthcare Corp · Jun 1993
AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET
K924207 · 3M Health Care, Ltd. · May 1993
INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET
K921899 · Baxter Healthcare Corp · Apr 1993
LIFESHIELD ANESTHESIA SET
K913982 · Abbott Laboratories · Nov 1992
INTERLINK(TM) INJECTION SITE
K922558 · Baxter Healthcare Corp · Oct 1992
SUBCUTANEOUS INFUSION SET
K920537 · Marquette Medical, Inc. · Oct 1992