510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K191910Substantially Equivalent

SpaceStation MRI

B. Braun Melsugen AG, Melsungen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191910 is the FDA 510(k) clearance record for SpaceStation MRI, a class II device, cleared for B. Braun Melsugen AG on under FDA product code MRZ (Accessories, Pump, Infusion). FDA records list one 510(k) clearance for B. Braun Melsugen AG. As of , FDA records show 8 recalls naming K191910.

Clearance record

Decision date
Received
(239 days to decision)
Product code
MRZ Accessories, Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
B. Braun Melsugen AG Carl-Braun-Strasse 1, Melsungen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRZ

Trailing 12 months

FDA records hold no clearances under product code MRZ in the trailing twelve months.

FDA records show no clearances under product code MRZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260