510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210862Substantially Equivalent

Hemafuse System

Sisu Global Health, Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K210862 is the FDA 510(k) clearance record for Hemafuse System, a class II device, cleared for Sisu Global Health on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list one 510(k) clearance for Sisu Global Health. As of , FDA records show no recalls naming K210862.

Clearance record

Decision date
Received
(128 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Sisu Global Health 2720 Sisson St., Baltimore MD
510(k) summary
Statement
Third party review
No

Clearances, product code CAC

Trailing 12 months

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

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