510(k) Report

FDA product code · Cardiovascular

Over-The-Counter Automated External Defibrillator

NSAClass III21 CFR 870.5310PMA required2 decisions since 20042 recalls

2 FDA decisions since 2004. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K040904, named by 2 later devices.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of NSA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NSA

2in 2025

2019: 22020: 42021: 62022: 52023: 42024: 42025: 22026 (partial year): 1
2007high 6 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NSA

Too few NSA 510(k)s in any year since 2007 to give a median.

Recalls per year · NSA

1in 2009

2008: 12009: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NSA

568in 2025

2010: 12011: 52012: 402013: 1082014: 1772015: 622016: 442017: 562018: 692019: 542020: 392021: 202022: 232023: 672024: 922025: 568
2007high 568 (2025) · low 0 (2007)2025

MAUDE reports naming product code NSA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
20090—10
20100—01
20110—05
20120—040
20130—0108
20140—0177
20150—062
20160—044
20170—056
20180—069
20192—054
20204—039
20216—020
20225—023
20234—067
20244—092
20252—0568
20261—0—
FIG. 1 — NSA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NSA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NSA devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K040904Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems · 20042cite it

Which NSA devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K040904Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems · 20041generation

What has FDA decided in NSA lately?

  • P160029HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)Philips Medical Systems, Inc. · 20195 recalls
  • K040904Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems · 20047 recalls

All 2 NSA decisions →

What has been recalled in NSA lately?

  • K040904Heartstart HS1 Defibrillator Model M5068APhilips Medical Systems · Nov 2, 2009
  • K040904Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the…Philips Medical Systems · Apr 30, 2008

Related product codes

Other codes under 21 CFR 870.5310.

MKJ Automated External Defibrillators (Non-Wearable)