510(k) · Cleared
ClearedBraemar Cardiokey Holter Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braemar Manufacturing, LLC · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Oct 16, 2013 as substantially equivalent to K071733 (Braemar, Inc., 2007) after a 252-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Oct 16, 2013
- Review
- 252 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071733 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK071733 DL900 Series Holter RecorderBraemar, Inc. · 2007 · Recalled
- This deviceK130294 Braemar Cardiokey Holter RecorderBraemar Manufacturing, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071733 | DL900 Series Holter Recorder | Braemar, Inc. | 2007 | 3 |
| 0 (this device) | K130294 | Braemar Cardiokey Holter Recorder | Braemar Manufacturing, LLC | 2013 | — |
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 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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K071733 | DL900 Series Holter RecorderSummary page 1…Predicate Device The predicate device is as follows: Braemar Model DL900 Series H-lter Recorder manufactured by Braemar, Inc. cleared by FDA under 510(k) number K071733; 870.2800 Product code MWJ Medical Magnetic Tape Recorder' on July 24, 2007 Device Description The CardioKey Hotter Re… | 2007 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K071733.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 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 CK100 CardioKey Holter Recorder is intended for patients requiring ambulatory (Holter) Monitoring. The following is a listing of the most frequent indications for use:
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 patients response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
5. Clinical and epidemiological research studies.
6. Reporting of time and frequency domain heart rate variability.
7. Reporting of QT Interval.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130294: Braemar Cardiokey Holter Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130294
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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