FDA product code NSA: Over-The-Counter Automated External Defibrillator
NSA is the FDA product code for over-the-counter automated external defibrillator. It is a Class III device, regulated under 21 CFR 870.5310 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under NSA. The average 510(k) review took 162 days (median 162). 2 PMA applications cite this product code. FDA has posted 2 recalls for NSA devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Over-The-Counter Automated External Defibrillator |
| Device class | Class III |
| Regulation | 21 CFR 870.5310 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every NSA clearance
Top NSA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Philips Medical Systems | 1 | 2004-09-16 |
Most recent NSA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040904 | Philips Medical Systems | PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A | 2004-09-16 | 162 |
Recalls for NSA devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-11-02.
Frequently asked questions
What is FDA product code NSA?
NSA is the FDA product code for over-the-counter automated external defibrillator. It is a Class III device, regulated under 21 CFR 870.5310 and reviewed by the Cardiovascular panel.
What device class is NSA?
Class III, regulation 21 CFR 870.5310. Typical premarket route: PMA.
How long does a 510(k) take for product code NSA?
Across 1 cleared submissions the average was 162 days from receipt to decision (median 162).
Which companies have the most NSA clearances?
Philips Medical Systems (1).
Have NSA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2009-11-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NSA
- Run a recall and safety report across every NSA manufacturer
- Watch product code NSA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times