Cleared Traditional

K974571 - SOLUTION ADMINISTRATION SET WITH CAPPED...

K974571 is the FDA 510(k) clearance for SOLUTION ADMINISTRATION SET WITH CAPPED... by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K974571 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
164d
Days
Class 2
Risk

K974571 is an FDA 510(k) clearance for the SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 21, 1998 after a review of 164 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K974571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1997
Decision Date May 21, 1998
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 465
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K974571.
SOLUTION ADMINISTRATION SET
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DUAL LUER LOCK CAP
K981318 · Baxter Healthcare Corp · Apr 1998
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
K974163 · Medtronic Minimed · Feb 1998