Cleared Traditional

B Dispensing Line (K203674) - FDA 510(k) Clearance

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

K203674 · Aea Srl · General Hospital
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Sep 2021
Decision
285d
Days
Class 2
Risk

K203674 is an FDA 510(k) clearance for the B Dispensing Line. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Aea Srl (Angeli De Rosora, IT). The FDA issued a Cleared decision on September 27, 2021 after a review of 285 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Aea Srl devices

Submission Details

510(k) Number K203674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2020
Decision Date September 27, 2021
Days to Decision 285 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
156d slower than avg
Panel avg: 129d · This submission: 285d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 64
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K203674.
freeflex+ Transfer Adapter
K212445 · Fresenius Kabi AG · Jun 2022
IVX Fluid Transfer Set
K212530 · Omnicell, Inc. · Apr 2022
SOL-CARE IV Bag Safety Connector
K202732 · Sol-Millennium Medical Group · Nov 2021
ProntoPump Sterile Tube Set
K200893 · Ipax, Inc. · May 2021
Mini Spike Plus 6/8R
K201469 · B.Braun Medical, Inc. · Dec 2020
Vial2Bag Advanced 20mm Admixture Device
K201415 · West Pharmaceutical Services Az, Inc. · Oct 2020