510(k) · Cleared

Cleared

DR180-II

K001288510(k) AbbreviatedCleared Jul 20, 200087-day reviewClass II21 CFR 870.2800

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

North East Monitoring, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)

Cleared on Jul 20, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 64 later devices descend from it.

Decided: Jul 20, 2000
Review: 87 days
Class: Class II
Product code: MWJ
Recalls: None
Predicates: 0

64 later devices descend from it, 3 citing it directly.

This deviceK001288 DR180-IINorth East Monitoring, Inc. · 2000
Descendant · cites it directly · 59 of its ownK022540 Cardio ID+(RZ153+)Rozinn Electronics, Inc. · 2002
Descendant · 2 generations on · 56 of its ownK032466 SpiderviewEla Medical, Inc. · 2003
Descendant · 2 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
Descendant · 3 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2002high 6 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 64 · See all

K022540Cardio ID+(RZ153+)Rozinn Electronics, Inc. · 2002 · cites it directly59descendants
K032466SpiderviewEla Medical, Inc. · 2003 · 2 generations on56descendants
K042108Vista PlusNovacor · 2005 · 2 generations on46descendants
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 3 generations on40descendants
K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 3 generations on30descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001288	DR180-II	North East Monitoring, Inc.	2000	—
+1	K022540	Cardio ID+(RZ153+)	Rozinn Electronics, Inc.	2002	—
+2	K032466	Spiderview	Ela Medical, Inc.	2003	—
+2	K042108	Vista Plus	Novacor	2005	—
+3	K071641	Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…	Medtronic, Inc.	2007	—
+3	K071655	Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…	Medtronic, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2005	3	0
2006	1	0
2007	3	0
2008	1	0
2010	2	0
2011	2	0
2012	1	0
2013	1	0
2014	5	0
2015	4	0
2016	5	0
2017	6	0
2018	1	0
2019	4	0
2020	4	0
2021	4	0
2022	2	0
2023	6	0
2024	1	0
2025	1	0
2026	4	0

FIG. 1 — Lineage of K001288, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Top candidate predicates for a new MWJ device

#1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (64)

See all 64

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022540	Cardio ID+(RZ153+)	Rozinn Electronics, Inc.	2002	59
K041901	SD360 Digital Recorder/SD360 Holter Digital Recorder	North East Monitoring, Inc.	2004	6
K102723	Model 950-12L Holter Recorder Without Analysis	Memtec Corp.	2010	3

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?

Of its descendants, K022540 (Rozinn Electronics, Inc., 2002) has gone furthest, with 59 descendants of its own.

How does its category compare?

All MWJ devices

MWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWJ

2in 2024

2007high 5 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWJ

337in 2022

2007high 337 (2022) · low 90 (2010)2026

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

Recalls per year · MWJ

2in 2024

2007high 2 (2024) · low 0 (2007)2026

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

Adverse event reports per year · MWJ

8in 2025

2007high 12 (2020) · low 0 (2007)2025

MAUDE reports naming product code MWJ, 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	5	142	0	0
2008	1	—	0	0
2009	2	—	0	5
2010	3	90	0	0
2011	3	206	0	0
2012	1	—	0	2
2013	3	241	0	4
2014	2	—	0	1
2015	0	—	0	1
2016	2	—	0	1
2017	0	—	0	2
2018	1	—	0	1
2019	0	—	0	4
2020	0	—	0	12
2021	1	—	0	3
2022	4	337	0	6
2023	0	—	0	5
2024	2	—	2	3
2025	0	—	0	8
2026	5	270	0	—

https://510kreport.com/device/K001288 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001288: DR180-II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001288

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026