510(k) · Cleared
ClearedCER-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiocalm · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Aug 26, 2020 as substantially equivalent to K042002 (Ela Medical, Inc., 2004) after a 282-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Aug 26, 2020
- Review
- 282 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930806 (1994). 22 ancestors in all, the oldest K871344 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 4 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 3 generations backK982090 Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc. · 1999
- 2 generations backK020213 Netlink/NetscanRozinn Electronics, Inc. · 2002
- 1 generation backK042002 Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004
- This deviceK193177 CER-SCardiocalm · 2020
- Descendant · cites it directly · 1 of its ownK213861 CER-SCardiocalm Srl · 2022
- Descendant · 2 generations on · 0 of its ownK243312 CER-SCardiocalm Srl · 2025
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 |
|---|---|---|---|---|---|
| −5 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −4 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −3 | K982090 | Paceart Home Trak Plus Easi Event Recorder System | Paceart, Inc. | 1999 | — |
| −2 | K020213 | Netlink/Netscan | Rozinn Electronics, Inc. | 2002 | — |
| −1 | K042002 | Synescope, Easyscope, Synecom, Holterreader | Ela Medical, Inc. | 2004 | — |
| 0 (this device) | K193177 | CER-S | Cardiocalm | 2020 | — |
| +1 | K213861 | CER-S | Cardiocalm Srl | 2022 | — |
| +2 | K243312 | CER-S | Cardiocalm Srl | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1990 | 3 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 MLO? 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 MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 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 |
|---|---|---|---|
| * | K042002 | Synescope, Easyscope, Synecom, HolterreaderSummary page 4…DQK Name of Predicate Device 510(k) # Manufacturer SyneScopeTM, EasyScopeTM, SyneComTM K042002 Sorin Group HolterReader (Ela Medic… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213861 | CER-S | 2022 | 1 |
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 26 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K213861 (Cardiocalm Srl, 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital continuous ECG recordings. CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device. The device provides the clinician an…
Read the full statement (151 words)
CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital continuous ECG recordings.
CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device.
The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart rhythm disorders in adult and pediatric patients.
Note: This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool.
CER-S analysis provides indications for, but not limited to, evaluation of:
Patients with rhythm disturbances (cardiac arrhythmias),
Patients with transient myocardial ischemia,
Patients with pacemaker (only if pacing detection is available from the input recording),
Patients needing HRV evaluation,
Newborn patients limited to QRS detection.
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/K193177 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193177: CER-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193177
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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