510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882592Substantially Equivalent

Heart Hugger Sternum Support Harness

General Cardiac Technology, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882592 is the FDA 510(k) clearance record for HEART HUGGER STERNUM SUPPORT HARNESS, a class I device, cleared for General Cardiac Technology, Inc. on under FDA product code KMO (Binder, Elastic). FDA records list one 510(k) clearance for General Cardiac Technology, Inc. As of , FDA records show no recalls naming K882592.

Clearance record

Decision date
Received
(89 days to decision)
Product code
KMO Binder, Elastic
Regulation
21 CFR 880.5160
Device class
Class I
Review panel
General Hospital
Applicant
General Cardiac Technology, Inc. 795 Carmel Ave., Sunnyvale CA
Third party review
No

Clearances, product code KMO

Trailing 12 months

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

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