510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080421Substantially Equivalent

Heart Sync, Models C-100 and T-100

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies, Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080421 is the FDA 510(k) clearance record for HEART SYNC, MODELS C-100 AND T-100, a class III device, cleared for Heart Sync, LLC on under FDA product code MKJ (Automated External Defibrillators (Non-Wearable)). FDA's definition for product code MKJ reads: "This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an...". FDA records list 6 510(k) clearances for Graphic Controls Acquisition Corp.dba Nissha Medical Technologies, from to . As of , FDA records show 11 recalls naming K080421.

Clearance record

Decision date
Received
(14 days to decision)
Product code
MKJ Automated External Defibrillators (Non-Wearable)
Regulation
21 CFR 870.5310
Device class
Class III
Review panel
Cardiovascular
Applicant
Heart Sync, LLC 5643 Plymouth Rd., Ann Arbor MI
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code MKJ

Trailing 12 months

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

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