510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K014157Substantially Equivalent - Subject to Tracking Reg.

Heartstreamfr2 AED with M3848a and M3849a, Models M3860a, M3861, M3840a, M3841a

Philips North America LLC, Seattle WA / Special, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K014157 is the FDA 510(k) clearance record for HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A, a class III device, cleared for Philips Medical Systems 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 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show 4 recalls naming K014157.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MKJ Automated External Defibrillators (Non-Wearable)
Regulation
21 CFR 870.5310
Device class
Class III
Review panel
Cardiovascular
Applicant
Philips Medical Systems 2401 Fourth Ave., Suite 500, Seattle WA
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