Cleared Traditional

K050339 - SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE

K050339 is an FDA 510(k) clearance for SET GRI-FILL 3.0-1 WAY, manufactured by Laboratorios Grifols, S.A.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K050339 · Laboratorios Grifols, S.A. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
14d
Days
Class 2
Risk

K050339 is an FDA 510(k) clearance for the SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Laboratorios Grifols, S.A. (Parets Del Valles, Barcelona, ES). The FDA issued a Cleared decision on February 25, 2005 after a review of 14 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 - K050339

510(k) Number K050339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2005
Decision Date February 25, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
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 Consultant

Underwriters Laboratories, Inc.
MORTEN S CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 169
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K050339.
PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS
K060866 · Carmel Pharma Ab. · Apr 2006
SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
K052790 · Cardinal Health, Alaris Products · Dec 2005
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K051669 · Migada Plant · Sep 2005
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
K043304 · Bioject Medical Technologies, Inc. · Jan 2005
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
K041222 · B.Braun Medical, Inc. · Oct 2004
BAXJECT II
K042410 · Baxter Healthcare Corp · Oct 2004

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.