Cleared Traditional

K040456 - FLEBOSET MULTIPLE

K040456 is an FDA 510(k) clearance for FLEBOSET MULTIPLE, 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 15-day FDA review.

K040456 · Laboratorios Grifols, S.A. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
15d
Days
Class 2
Risk

K040456 is an FDA 510(k) clearance for the FLEBOSET 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 March 9, 2004 after a review of 15 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 - K040456

510(k) Number K040456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2004
Decision Date March 09, 2004
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
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 K040456.
GETTIG UNIVERSAL VIAL ACCESS PIN
K041232 · Gettig Pharmaceutical Instrument Co. · Jul 2004
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
K041564 · Bioject Medical Technologies, Inc. · Jul 2004
ROBERTSITE VIAL ADAPTER, MODEL 245700021
K040634 · Halkey-Roberts Corp. · Mar 2004
SET GRI-FILL 2.0-1 WAY
K033682 · Laboratorios Grifols, S.A. · Dec 2003
MIX2VIAL TRANSFER DEVICE
K031861 · Medimop Medical Projects, Ltd. · Jul 2003
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003

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.