510(k) · Cleared
ClearedChroma, Model: RZ153C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scottcare Corporation · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Aug 13, 2009 as substantially equivalent to K993618 (Braemar Corp., 1999) after a 272-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Aug 13, 2009
- Review
- 272 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950944 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K993618 | DXP1000 Holter RecorderSummary page 1…Medical Magnetic Tape Recorder Product Code: DSH Legally Marketed DXP 1000 Holter Recorder Predicate Device(s): K993 618, November 24, 1999… | 1999 |
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 13 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K993618.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 intended use of the Chroma Holter Recorder RZ153C is to perform
ambulatory ECG on the order of a physician, on those patients who may benefit
from such a recording, including, but not limited to, those with complaints of
palpitations, syncope, chest pain, shortness of breath, or those that need to be
monitored to judge their current cardiac functionality such as patients who have
recently received pacemakers. The data obtained at recording is not analyzed at the
time of the recording.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083382: Chroma, Model: RZ153C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083382
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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