Cleared Traditional

SpaceStation MRI (K191910) - FDA 510(k) Clearance

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

K191910 · B. Braun Melsugen AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
239d
Days
Class 2
Risk

K191910 is an FDA 510(k) clearance for the SpaceStation MRI. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by B. Braun Melsugen AG (Melsungen, DE). The FDA issued a Cleared decision on March 12, 2020 after a review of 239 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 B. Braun Melsugen AG devices

Submission Details

510(k) Number K191910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2019
Decision Date March 12, 2020
Days to Decision 239 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
110d slower than avg
Panel avg: 129d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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

Emergo Global Consulting, LLC
Andre Kindsvater

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 - MRZ Accessories, Pump, Infusion

All 47
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K191910.
UTC 3mL Medication Cartridge
K230718 · Gilero, LLC · Jun 2023
Elite Biomedical Solutions Dose Request Cord
K220695 · Elite Biomedical Solutions · Apr 2022
RG 3ml Medication Cartridge
K201634 · Chengdu Shifeng Medical Technology Co., Ltd. · Mar 2021
BlueStar Rx
K193654 · Welldoc, Inc. · Apr 2020
WellDoc BlueStar
K190013 · Welldoc, Inc. · Nov 2019
Lockbox for Perfusor Space PCA Infusion Pump
K173531 · B.Braun Medical, Inc. · Aug 2018