510(k) · Cleared
ClearedLifecard CF 7 Day
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reynolds Medical, Ltd. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jul 13, 2001 as substantially equivalent to K001025 (Reynolds Medical, Ltd., 2000) after a 31-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jul 13, 2001
- Review
- 31 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001025 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001025 Lifecard CF Compact RecorderReynolds Medical, Ltd. · 2000
- This deviceK011837 Lifecard CF 7 DayReynolds Medical, Ltd. · 2001
- Descendant · cites it directly · 0 of its ownK212317 Eclipse MINI Model 98900Spacelabs Healthcare, Ltd. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK211651 Eclipse PROSpacelabs Healthcare, Ltd. · 2021 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001025 | Lifecard CF Compact Recorder | Reynolds Medical, Ltd. | 2000 | — |
| 0 (this device) | K011837 | Lifecard CF 7 Day | Reynolds Medical, Ltd. | 2001 | — |
| +1 | K212317 | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | 2022 | 1 |
| +1 | K211651 | Eclipse PRO | Spacelabs Healthcare, Ltd. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
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 |
|---|---|---|---|
| * | K001025 | Lifecard CF Compact RecorderSummary page 1…Recorder, Magnetic Tape, Medical (please note that this device does not use magnetic tape) (3) Equivalent legally-marketed device. Reynolds Lifecard CF Holter recorder, K001025 (4) Description The device is a portable Holter recorder designed to record the patient’s ambulatory electrocardiogram for up t… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Reynolds Lifecard CF 7-Day Holter recorder is a modification of the Reynolds Lifecard CF Holter Recorder, K001025. It is indicated when it is desired to record the patient’s ambulatory electrocardiogram.
It is a portable Holter recorder designed to record the patient’s ambulatory electrocardiogram for up to seven days.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011837 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011837: Lifecard CF 7 Day.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011837
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026