Cleared Traditional

Empty EVA Bag (K193528) - FDA 510(k) Clearance

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

K193528 · Haemotronic S.P.A. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
216d
Days
Class 2
Risk

K193528 is an FDA 510(k) clearance for the Empty EVA Bag. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Haemotronic S.P.A. (Mirandola, IT). The FDA issued a Cleared decision on July 22, 2020 after a review of 216 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.

View all Haemotronic S.P.A. devices

Submission Details

510(k) Number K193528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2019
Decision Date July 22, 2020
Days to Decision 216 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 129d · This submission: 216d
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.

All 29
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K193528.
Disposable Infusion Bag for Parenteral Nutrition
K222622 · Beijing L&Z Medical Technology Development Co., Ltd. · Feb 2023
Empty EVA Bag
K210749 · Haemotronic S.P.A. · Aug 2021
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
K201936 · Gilero, LLC · May 2021
HCT Empty EVA Container Pack
K190328 · Health Care Technologies · Aug 2019
Additive Cap
K190305 · International Medical Industries, Inc. · Apr 2019
Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
K181393 · Valmed S.R.L. · Feb 2019