NSAClass III

Over-The-Counter Automated External Defibrillator

21 CFR 870.5310 / Cardiovascular

NSA is the FDA product code for Over-The-Counter Automated External Defibrillator, a class III device type, regulated under 21 CFR 870.5310. FDA's definition for this code 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 sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2004-09-16, and 2 recalls.

Classification record

Product code: NSA
Device name: Over-The-Counter Automated External Defibrillator
FDA definition: 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 sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.
Regulation: 21 CFR 870.5310
Device class: Class III
Review panel: Cardiovascular
Submission type: PMA
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 2

Clearances, product code NSA

By decision year

1 clearance under product code NSA with a decision year between 2004 and 2004, 2004 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NSA by decision year
Year	Clearances
2004	1

Applicants with the most clearances

Product code NSA

Applicants holding the most 510(k) clearances under product code NSA
Applicant	Clearances
Philips North America LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code NSA

K040904Class IIIPhilips Heartstart Home Defibrillator, Model M5068aPhilips Medical Systems / cleared 2004-09-16

Recent recalls

Product code NSA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)