510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841958Substantially Equivalent

Cardio Metrics Cardiotomy Reservoir

Sterile Design, Inc., Oldsmar FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841958 is the FDA 510(k) clearance record for CARDIO METRICS CARDIOTOMY RESERVOIR, a class II device, cleared for Sterile Design, Inc. on under FDA product code JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass). FDA records list 10 510(k) clearances for Sterile Design, Inc., from to . As of , FDA records show no recalls naming K841958.

Clearance record

Decision date
Received
(154 days to decision)
Product code
JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4270
Device class
Class II
Review panel
Cardiovascular
Applicant
Sterile Design, Inc. P.O. Box 12100, Oldsmar FL
Third party review
No

Clearances, product code JOD

Trailing 12 months

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

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