510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102033Substantially Equivalent

Combitrans Monitoring Sets and Accessories

B.Braun Melsungen AG, Allentown PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102033 is the FDA 510(k) clearance record for COMBITRANS MONITORING SETS AND ACCESSORIES, a class II device, cleared for B.Braun Melsungen AG on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list 5 510(k) clearances for B.Braun Melsungen AG, from to . As of , FDA records show no recalls naming K102033.

Clearance record

Decision date
Received
(262 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
B.Braun Melsungen AG 901 Marcon Blvd., Allentown PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRS

Trailing 12 months
1 clearance under product code DRS in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRS, 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 20261
October 20260