Cleared Traditional

nextaro Transfer System, nextaro va (K183187) - FDA 510(k) Clearance

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

K183187 · Sfm Medical Devices GmbH · General Hospital
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Mar 2019
Decision
116d
Days
Class 2
Risk

K183187 is an FDA 510(k) clearance for the nextaro Transfer System, nextaro va. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Sfm Medical Devices GmbH (Waechtersbach, DE). The FDA issued a Cleared decision on March 15, 2019 after a review of 116 days - within the typical 510(k) review window.

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 Sfm Medical Devices GmbH devices

Submission Details

510(k) Number K183187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date March 15, 2019
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 129d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Mark Job

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K183187.
Decanting Device
K182819 · Gcmedica Enterprise Ltd.(Wuxi) · Dec 2019
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
K190816 · Avenir Performance Europeenne Medical (Apem) · Nov 2019
Vial Adapter Ø20 mm
K190149 · Avenir Performance Europeenne Medical (Apem) · Oct 2019
Guarded Luer Connector
K173577 · International Medical Industries, Inc. · Jun 2018
APEX Compounding System Transfer Set
K151423 · B.Braun Medical, Inc. · Feb 2016
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.