510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023854Substantially Equivalent

Samaritan AED, Model Sam-01

HeartSine Technologies Ltd, Mission Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023854 is the FDA 510(k) clearance record for SAMARITAN AED, MODEL SAM-01, a class III device, cleared for Heartsine Technologies, Inc. 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 Heartsine Technologies, Inc., from to . As of , FDA records show one recall naming K023854.

Clearance record

Decision date
Received
(87 days to decision)
Product code
MKJ Automated External Defibrillators (Non-Wearable)
Regulation
21 CFR 870.5310
Device class
Class III
Review panel
Cardiovascular
Applicant
Heartsine Technologies, Inc. 25892 Jamon Ln., Mission Viejo CA
510(k) summary
Summary PDF
Third party review
No

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