510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081442Substantially Equivalent

Heart Sync Pediatric, Model Ped-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)

K081442 is the FDA 510(k) clearance record for HEART SYNC PEDIATRIC, MODEL PED-100, a class II device, cleared for Heart Sync, LLC on under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)). FDA records list 6 510(k) clearances for Graphic Controls Acquisition Corp.dba Nissha Medical Technologies, from to . As of , FDA records show no recalls naming K081442.

Clearance record

Decision date
Received
(125 days to decision)
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Regulation
21 CFR 870.5300
Device class
Class II
Review panel
Cardiovascular
Applicant
Heart Sync, LLC 5643 Plymouth Rd., Ann Arbor MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LDD

Trailing 12 months

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

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