510(k) · Cleared
ClearedCER-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiocalm Srl · DQK Computer, Diagnostic, Programmable
Cleared on Feb 20, 2025 as substantially equivalent to K213861 (Cardiocalm Srl, 2022) after a 121-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Feb 20, 2025
- Review
- 121 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930806 (1994). 24 ancestors in all, the oldest K871344 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 6 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 5 generations backK982090 Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc. · 1999
- 4 generations backK020213 Netlink/NetscanRozinn Electronics, Inc. · 2002
- 3 generations backK042002 Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004
- 2 generations backK193177 CER-SCardiocalm · 2020
- 1 generation backK213861 CER-SCardiocalm Srl · 2022
- This deviceK243312 CER-SCardiocalm Srl · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −6 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −5 | K982090 | Paceart Home Trak Plus Easi Event Recorder System | Paceart, Inc. | 1999 | — |
| −4 | K020213 | Netlink/Netscan | Rozinn Electronics, Inc. | 2002 | — |
| −3 | K042002 | Synescope, Easyscope, Synecom, Holterreader | Ela Medical, Inc. | 2004 | — |
| −2 | K193177 | CER-S | Cardiocalm | 2020 | — |
| −1 | K213861 | CER-S | Cardiocalm Srl | 2022 | — |
| 0 (this device) | 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 |
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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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 |
|---|---|---|---|
| * | K213861 | CER-SSummary page 5…DQK Name of Predicate Device 510(k) # Manufacturer CER-S K213861 CardioCalm Srl Reason for Intention to introduce into commercial distribution a device, CER-S, th… | 2022 |
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 31 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 24 ancestors have a recall of any class.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
CER-S is a medical device stand-alone software intended for the analysis, editing, review and reporting of continuous ECG digital recordings, to support the clinician in the interpretation of the trace and the diagnosis of cardiac rhythm disorders in adult and pediatric patients. 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…
Read the full statement (148 words)
CER-S is a medical device stand-alone software intended for the analysis, editing, review and reporting of continuous ECG digital recordings, to support the clinician in the interpretation of the trace and the diagnosis of cardiac rhythm disorders in adult and pediatric patients.
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.
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 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 as stated in the FDA summary.
https://510kreport.com/device/K243312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243312: CER-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243312
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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