510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040904Substantially Equivalent

Philips Heartstart Home Defibrillator, Model M5068a

Philips North America LLC, Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040904 is the FDA 510(k) clearance record for PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A, a class III device, cleared for Philips Medical Systems on under FDA product code NSA (Over-The-Counter Automated External Defibrillator). FDA's definition for product code NSA reads: "Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of...". FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show 7 recalls naming K040904.

Clearance record

Decision date
Received
(162 days to decision)
Product code
NSA Over-The-Counter Automated External Defibrillator
Regulation
21 CFR 870.5310
Device class
Class III
Review panel
Cardiovascular
Applicant
Philips Medical Systems 2301 5th Ave., Suite 200, Seattle WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NSA

Trailing 12 months

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

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