510(k) · Cleared
ClearedLifecard CF Compact Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reynolds Medical, Ltd. · DSH Recorder, Magnetic Tape, Medical
Cleared on Apr 19, 2000 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Apr 19, 2000
- Review
- 20 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK001025 Lifecard CF Compact RecorderReynolds Medical, Ltd. · 2000
- Descendant · cites it directly · 3 of its ownK071085 E3-80 Portable Ecg Recorder & AnalyzerMicro-Star International Co., Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK101569 V-Trust Model TD-2202 Portable Ecg RecorderTaidoc Technology Corporation · 2011
- Descendant · cites it directly · 2 of its ownK011837 Lifecard CF 7 DayReynolds Medical, Ltd. · 2001
- Descendant · 2 generations on · 0 of its ownK212317 Eclipse MINI Model 98900Spacelabs Healthcare, Ltd. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK211651 Eclipse PROSpacelabs Healthcare, Ltd. · 2021 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K071085E3-80 Portable Ecg Recorder & AnalyzerMicro-Star International Co., Ltd. · 2007 · cites it directly3descendants
- K101569V-Trust Model TD-2202 Portable Ecg RecorderTaidoc Technology Corporation · 2011 · 2 generations on2descendants
- K011837Lifecard CF 7 DayReynolds Medical, Ltd. · 2001 · cites it directly2descendants
- K212317Eclipse MINI Model 98900Spacelabs Healthcare, Ltd. · 2022 · 2 generations on0descendants
- K211651Eclipse PROSpacelabs Healthcare, Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001025 | Lifecard CF Compact Recorder | Reynolds Medical, Ltd. | 2000 | — |
| +1 | K071085 | E3-80 Portable Ecg Recorder & Analyzer | Micro-Star International Co., Ltd. | 2007 | — |
| +2 | K101569 | V-Trust Model TD-2202 Portable Ecg Recorder | Taidoc Technology Corporation | 2011 | — |
| +1 | K011837 | Lifecard CF 7 Day | Reynolds Medical, Ltd. | 2001 | — |
| +2 | K212317 | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | 2022 | 1 |
| +2 | K211651 | Eclipse PRO | Spacelabs Healthcare, Ltd. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 18.0 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (8)
3 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?
- Of its descendants, K071085 (Micro-Star International Co., Ltd., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K001025 · printed Nov 3, 2026
Cite this page
510(k) Report. “K001025: Lifecard CF Compact Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K001025
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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