Cleared Traditional

K193528 - Empty EVA Bag

K193528 is an FDA 510(k) clearance for Empty EVA Bag, manufactured by Haemotronic S.P.A.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K193528 · Haemotronic S.P.A. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K193528

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.

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 43
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