510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103168Substantially Equivalent

B-Care5 (B-Care5 Sensor Module, Venous Sensor, Holder for Measuring Head)

LivaNova Deutschland GmbH, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103168 is the FDA 510(k) clearance record for B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD), a class II device, cleared for Sorin Group Deutschland GmbH on under FDA product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass). FDA records list 27 510(k) clearances for LivaNova Deutschland GmbH, from to . As of , FDA records show no recalls naming K103168.

Clearance record

Decision date
Received
(71 days to decision)
Product code
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4330
Device class
Class II
Review panel
Cardiovascular
Applicant
Sorin Group Deutschland GmbH 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRY

Trailing 12 months

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

FDA records show no clearances under product code DRY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRY, 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