510(k) · Cleared

Cleared

I-PAD

K062970510(k) TraditionalCleared Jan 22, 2008480-day reviewClass III21 CFR 870.5310

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

Cu Medical Systems, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Jan 22, 2008 as substantially equivalent to K020715 (Philips Medical Systems, 2002) and 2 other predicates after a 480-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jan 22, 2008
Review: 480 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K955628 (1996). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
1 generation backK013896 Sentry Semiautomatic External Defibrillator; External Defibrillation…Defibtech, LLC · 2002 · Recalled
This deviceK062970 I-PADCu Medical Systems, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K955628	Fore Runner External Defibrillator/Defibrillator Pads	Heartstream, Inc.	1996	—
−1	K013896	Sentry Semiautomatic External Defibrillator; External Defibrillation Pads…	Defibtech, LLC	2002	5
0 (this device)	K062970	I-PAD	Cu Medical Systems, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	2	0

FIG. 1 — Lineage of K062970, 1996–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K020715	Philips M5066A and M5068A Summary page 1 …y the following: Device Name Manufacturer 5 10(K) Number Philips HeartStart OnSite Philips Medical Systems K020715 Philips HeartStart FR2+ Philips Medical Systems K013425 Defibtech Sentry DDU-100A Defibtech, LLC…	Philips Medical Systems	2002	12
*	K013425	Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A Summary page 1 …5 10(K) Number Philips HeartStart OnSite Philips Medical Systems K020715 Philips HeartStart FR2+ Philips Medical Systems K013425 Defibtech Sentry DDU-100A Defibtech, LLC K013896 The shock delivered by the device is in the form of…	Philips Medical Systems	2002	10
*	K013896	Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)… Summary page 1 …stems K020715 Philips HeartStart FR2+ Philips Medical Systems K013425 Defibtech Sentry DDU-100A Defibtech, LLC K013896 The shock delivered by the device is in the form of a Biphasic Truncated Exponential which has characteristics and results that…	Defibtech, LLC	2002	5

Also cleared against K020715: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
3 of the 5 ancestors have a recall of any class.
6 other devices also cite its predicate K020715.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MKJ

48in 2025

2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007high 17,062 (2016) · low 3,958 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	69	12	3,958
2008	13	141	24	4,752
2009	8	165	37	6,782
2010	4	250	35	7,399
2011	11	36	7	8,170
2012	10	197	5 (1)	9,732
2013	7	191	4	14,955
2014	11	196	24 (15)	15,399
2015	6	156	1	16,129
2016	0	—	2 (1)	17,062
2017	4	—	6 (4)	16,684
2018	20	—	3	16,591
2019	25	—	6 (2)	16,861
2020	52	—	2	16,197
2021	41	—	4	16,300
2022	19	—	3	14,867
2023	24	—	11	13,766
2024	27	—	5	15,109
2025	48	—	1	13,315
2026	31	—	3	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062970 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062970: I-PAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062970

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026