Cleared Traditional

K033682 - SET GRI-FILL 2.0-1 WAY

Also marketed or referenced as:
2.0-2 WAYS LUER CONNECTION TUBE

K033682 is an FDA 510(k) clearance for SET GRI-FILL 2.0-1 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 23-day FDA review.

K033682 · Laboratorios Grifols, S.A. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
23d
Days
Class 2
Risk

K033682 is an FDA 510(k) clearance for the SET GRI-FILL 2.0-1 WAY. 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 December 17, 2003 after a review of 23 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 - K033682

510(k) Number K033682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2003
Decision Date December 17, 2003
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
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.
SUSAN GILL

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 K033682.
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
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ROBERTSITE VIAL ADAPTER, MODEL 245700021
K040634 · Halkey-Roberts Corp. · Mar 2004
FLEBOSET MULTIPLE
K040456 · Laboratorios Grifols, S.A. · Mar 2004
MIX2VIAL TRANSFER DEVICE
K031861 · Medimop Medical Projects, Ltd. · Jul 2003
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003
STERI-SPOUTS
K023539 · Valumed · Dec 2002

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.