Cleared Abbreviated

K093182 - SET GRI-FILL 3.0

K093182 is an FDA 510(k) clearance for SET GRI-FILL 3.0, manufactured by Laboratorios Grifols, S.A.. The device is a Class 2 General Hospital device with product code LHI cleared through the Abbreviated 510(k) pathway after a 111-day FDA review.

K093182 · Laboratorios Grifols, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
111d
Days
Class 2
Risk

K093182 is an FDA 510(k) clearance for the SET GRI-FILL 3.0. 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 January 27, 2010 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Laboratorios Grifols, S.A. devices

FDA 510(k) Submission Details - K093182

510(k) Number K093182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2009
Decision Date January 27, 2010
Days to Decision 111 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Standards-based clearance path.

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 Peers - LHI Set, I.v. Fluid Transfer

All 79
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K093182.
DUAL SPIKE TRANSFER DEVICE
K120150 · B.Braun Medical, Inc. · May 2012
MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
K100640 · B.Braun Medical, Inc. · Jul 2010
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
K092246 · Nipro Medical Corporation · Nov 2009
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
K092318 · Baxter Healthcare Corporation · Oct 2009
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · B.Braun Medical, Inc. · Apr 2009