Cleared Traditional

K101412 - EVA TPN BAG

K101412 is an FDA 510(k) clearance for EVA TPN BAG, manufactured by Valmed S.R.L.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K101412 · Valmed S.R.L. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
328d
Days
Class 2
Risk

K101412 is an FDA 510(k) clearance for the EVA TPN BAG. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Valmed S.R.L. (Mazzo Di Valtellina So, IT). The FDA issued a Cleared decision on April 13, 2011 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Valmed S.R.L. devices

FDA 510(k) Submission Details - K101412

510(k) Number K101412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2010
Decision Date April 13, 2011
Days to Decision 328 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 129d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 56
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K101412.
STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
K132276 · Hospira, Inc. · Nov 2013
EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
K121161 · Acta Medical, LLC · Jul 2012
ADDITIVE CAP
K111217 · Baxter Healthcare Corp · Jun 2011
ALL-IN-ONE CONTAINER
K090096 · Baxter Healthcare Corporation · Jan 2009
DUAL CHAMBER TPN CONTAINER
K073538 · B.Braun Medical, Inc. · Mar 2008
EVA TPN CONTAINER
K041415 · B.Braun Medical, Inc. · Aug 2004