Cleared Special

K003225 - SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE

K003225 is an FDA 510(k) clearance for SOLUTION ADMINISTRATION SETS WITH CAPLE..., manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 3-day FDA review.

K003225 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
3d
Days
Class 2
Risk

K003225 is an FDA 510(k) clearance for the SOLUTION ADMINISTRATION SETS WITH CAPLESS 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 October 19, 2000 after a review of 3 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003225

510(k) Number K003225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2000
Decision Date October 19, 2000
Days to Decision 3 days
Submission Type Special
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
126d faster than avg
Panel avg: 129d · This submission: 3d
Pathway characteristics
Modification to existing cleared device.

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 1177
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K003225.
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
K003283 · Sterling Medivations, Inc. · Dec 2000
SIMPLICITY SOFT INFUSION SET
K002492 · Sterling Medivations, Inc. · Oct 2000
JETCAN HUBER NEEEDLE SET
K002471 · Pfm Produkte Fur Die Medizin AG · Oct 2000
ACTI-FLEX IV ADMINISTRATION SET
K001599 · R-Group Intl. · Sep 2000
I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411
K001872 · Codan US Corp. · Sep 2000
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
K002138 · Maersk Medical A/S · Aug 2000
K003225 · SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
Download PDF FDA Summary Baxter Healthcare Corp