Cleared Traditional

K181393 - Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181393 · Valmed S.R.L. · General Hospital
Feb 2019
Decision
262d
Days
Class 2
Risk

K181393 is an FDA 510(k) clearance for the Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, .... Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Valmed S.R.L. (Tovo Sant'Agata, IT). The FDA issued a Cleared decision on February 15, 2019 after a review of 262 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.

Submission Details

510(k) Number K181393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2018
Decision Date February 15, 2019
Days to Decision 262 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 169d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K181393.
ClaveQS™ Bag
K251980 · Icu Medical, Inc. · Mar 2026
KabiHelp® Uno
K251139 · Fresenius Kabi AG · Jan 2026
eZSURE™ Empty Fluid Container
K252094 · Epic Medical Pte. , Ltd. · Aug 2025
DMRX 100ml Empty Container Solution
K250459 · Technoflex Sas. · Apr 2025
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site
K241442 · Epic Medical Pte. , Ltd. · Jun 2024
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
K223674 · Epic Medical Pte. , Ltd. · Sep 2023