# K062970: I-PAD

- Pathway: 510(k) (Traditional)
- Applicant: Cu Medical Systems, Inc.
- Decided: Jan 22, 2008 after 480 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955628 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020715: Philips M5066A and M5068A, Philips Medical Systems (2002) Summary page 1.
- K013425: Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A, Philips Medical Systems (2002) Summary page 1.
- K013896: Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack 1200MAH; BA, Defibtech, LLC (2002) Summary page 1.

## Indications for use
The i-PAD NF1200 is used to treat a person suffering from sudden cardiac arrest (SCA) and who exhibits symptoms of * No movement and no response when shaken * No normal breathing

Source page: https://510kreport.com/device/K062970
Methodology: https://510kreport.com/methodology