510(k) · Cleared

Recalled · Class II · 2020

DL900 Series Holter Recorder

K071733510(k) SpecialCleared Jul 24, 200728-day reviewClass II21 CFR 870.2800Recalls 3

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

Braemar, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)

Cleared on Jul 24, 2007 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 3 times.

Decided: Jul 24, 2007
Review: 28 days
Class: Class II
Product code: MWJ
Recalls: 3
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK071733 DL900 Series Holter RecorderBraemar, Inc. · 2007
Descendant · cites it directly · 0 of its ownK130294 Braemar Cardiokey Holter RecorderBraemar Manufacturing, LLC · 2013
Descendant · cites it directly · 0 of its ownK101969 MH1 Microholter RecorderExelys, LLC · 2011

Most influential descendants

Showing 2 of 2 · See all

K130294Braemar Cardiokey Holter RecorderBraemar Manufacturing, LLC · 2013 · cites it directly0descendants
K101969MH1 Microholter RecorderExelys, LLC · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K071733	DL900 Series Holter Recorder	Braemar, Inc.	2007	—
+1	K130294	Braemar Cardiokey Holter Recorder	Braemar Manufacturing, LLC	2013	—
+1	K101969	MH1 Microholter Recorder	Exelys, LLC	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0

FIG. 1 — Lineage of K071733, 2007–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K130294	Braemar Cardiokey Holter Recorder	Braemar Manufacturing, LLC	2013	0
K101969	MH1 Microholter Recorder	Exelys, LLC	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 22, 2020	Class II	Z-1460-2020	Software design	An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in…
Jan 22, 2020	Class II	Z-1459-2020	Software design	An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in…
Jan 13, 2020	Class II	Z-1345-2020	Device Design	if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to function for a new patient study.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K130294 (Braemar Manufacturing, LLC, 2013) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.

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	—

What is it indicated for?

The DL900 Series Hotter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the indications below: 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of a patient's response after resuming…

Read the full statement (99 words)

The DL900 Series Hotter Recorder is intended for patients requiring ambulatory (Holter)

monitoring. Such monitoring is most frequently used for the indications below:

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

2. Evaluation of ECG documenting therapeutic interventions in individual patients or

groups of patients.

3. Evaluation of patients for ST segment changes.

4. Evaluation of a patient's response after resuming occupational or recreational

activities (e.g., after M.I. or cardiac surgery.)

5. Clinical and epidemiological research studies.

6. Evaluation of patients with pacemakers.

7. Reporting of time and frequency domain heart rate variability.

8. Reporting of QT Interval

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K071733 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071733: DL900 Series Holter Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071733

Report an extraction error

Are you the manufacturer?

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