Cleared Traditional

K031419 - GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML

K031419 is an FDA 510(k) clearance for GRI-FLEX, manufactured by Laboratorios Grifols, S.A.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K031419 · Laboratorios Grifols, S.A. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
203d
Days
Class 2
Risk

K031419 is an FDA 510(k) clearance for the GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Laboratorios Grifols, S.A. (Parets Del Valles, Barcelona, ES). The FDA issued a Cleared decision on November 24, 2003 after a review of 203 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K031419

510(k) Number K031419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date November 24, 2003
Days to Decision 203 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
74d slower than avg
Panel avg: 129d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KPE Device Classification - Class 2, Special Controls

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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.
PAMELA GWYNN

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 - KPE Container, I.v.

All 67
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K031419.
CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
K041038 · Churchill Medical Systems, Inc. · Dec 2004
EVA TPN CONTAINER
K041415 · B.Braun Medical, Inc. · Aug 2004
GRI-BAG, GRI-BAG AP
K033916 · Laboratorios Grifols, S.A. · Dec 2003
EVA EMPTY SOLUTION CONTAINER
K030888 · Metrix Co. · Apr 2003
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · Baxter Healthcare Corp · Mar 2002
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
K001461 · Biometrix , Ltd. · Sep 2000

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.