Cleared Traditional

K972957 - SA-EF MULTI-LUMEN EXTENSION SET

K972957 is an FDA 510(k) clearance for SA-EF MULTI-LUMEN EXTENSION SET, 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 49-day FDA review.

K972957 · Vlv Associates, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
49d
Days
Class 2
Risk

K972957 is an FDA 510(k) clearance for the SA-EF MULTI-LUMEN EXTENSION SET. 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 September 29, 1997 after a review of 49 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 Vlv Associates, Inc. devices

FDA 510(k) Submission Details - K972957

510(k) Number K972957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1997
Decision Date September 29, 1997
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 645
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K972957.
MEDCORP FLOW I.V. REGULATOR EXTENSION SET
K971004 · Medcorp Intl. · Oct 1997
AMSINO I.V. ADMINISTRATION SET
K973107 · Amsino Intl., Inc. · Oct 1997
CORE RESISTANT HUBER INFUSION SETS
K972712 · Icu Medical, Inc. · Oct 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
K972493 · Nipro Medical Corp. · Sep 1997
PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
K972527 · Quality System Consulting · Sep 1997
DYE STOP AND SAVE - QUICKFILL
K971624 · Shepherd Laboratories, Inc. · Sep 1997