Cleared Traditional

K033916 - GRI-BAG, GRI-BAG AP

K033916 is an FDA 510(k) clearance for GRI-BAG, 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 12-day FDA review.

K033916 · 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
12d
Days
Class 2
Risk

K033916 is an FDA 510(k) clearance for the GRI-BAG, GRI-BAG AP. 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 December 30, 2003 after a review of 12 days - a notably fast clearance 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: 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 - K033916

510(k) Number K033916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2003
Decision Date December 30, 2003
Days to Decision 12 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 129d · This submission: 12d
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 Peers - KPE Container, I.v.

All 67
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K033916.
KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
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CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
K041038 · Churchill Medical Systems, Inc. · Dec 2004
EVA TPN CONTAINER
K041415 · B.Braun Medical, Inc. · Aug 2004
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
K031419 · Laboratorios Grifols, S.A. · Nov 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