510(k) · Cleared
ClearedEzsleep Sleep Quality Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Platinum Team Co., Ltd. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Mar 22, 2012 as substantially equivalent to K993617 (Braemar Corp., 1999) and 1 other predicate after a 198-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Mar 22, 2012
- Review
- 198 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950944 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −1 | K993617 | Digitrakplus Holter Recorder | Braemar Corp. | 1999 | — |
| 0 (this device) | K112573 | Ezsleep Sleep Quality Recorder | Platinum Team Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K993617 | Digitrakplus Holter RecorderSummary page 1…MWJ 3. Predicate Device Trade Name 510Ok Number Decision Date Braemar DigiTrak Plus Holter Recorder K993617 11/24/1999 Del Mar Lifecard CF Compact Holter Recorder K00 1025 04/19/2000 4. Device Descrip… | 1999 |
| * | K001025 | Lifecard CF Compact RecorderSummary page 1…Number Decision Date Braemar DigiTrak Plus Holter Recorder K993617 11/24/1999 Del Mar Lifecard CF Compact Holter Recorder K00 1025 04/19/2000 4. Device Description The EZsleep Sleep Quality Recorder is a small battery powered device designed to… | 2000 |
| † | K070855 | Sleep Quality | 2008 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 3 ancestors has a recall.
- 6 other devices also cite its predicate K993617.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 EZsleep Sleep Quality Recorder is to be placed on patient's chest for recording of heart rate signals while patient is asleep. The recorded data is for sleep quality analysis.
The EZsleep Sleep Quality Recorder is not intended for monitoring purpose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112573 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112573: Ezsleep Sleep Quality Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112573
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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