510(k) · Cleared
ClearedILR ECG Analyzer (IM007)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implicity, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Jul 2, 2026 as substantially equivalent to K210543 (Implicity, Inc., 2021) after a 267-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jul 2, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003621 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
- 5 generations backK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
- 4 generations backK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
- 3 generations backK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
- 2 generations backK170568 CardioLogs ECG Analysis PlatformCardiologs Technologies · 2017
- 1 generation backK210543 IM007Implicity, Inc. · 2021
- This deviceK253463 ILR ECG Analyzer (IM007)Implicity, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | 2000 | — |
| −5 | K013717 | Brentwood Real Time ST and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | 2002 | — |
| −4 | K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | 2005 | — |
| −3 | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | 2007 | — |
| −2 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | 2017 | — |
| −1 | K210543 | IM007 | Implicity, Inc. | 2021 | — |
| 0 (this device) | K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026 | — |
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 26.7 · 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 |
|---|---|---|---|
| * | K210543 | IM007Summary page 8…me device Manufacturer IMPLICITY INC IMPLICITY INC Same 510(k) # K210543 NA Regulation 21 CFR 870.1425 21 CFR 870.1425… | 2021 |
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 26 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
IM007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. IM007 supports analyzing data recorded in compatible formats from ICMs. This version of IM007 supports ECG data from compatible Abbott, Biotronik, Boston Scientific and Medtronic ICMs. The device is intended for use in adult patients (18 years and older) who have been implanted with a compatible ICM for diagnosis…
Read the full statement (180 words)
IM007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data.
IM007 supports analyzing data recorded in compatible formats from ICMs.
This version of IM007 supports ECG data from compatible Abbott, Biotronik, Boston Scientific and Medtronic ICMs.
The device is intended for use in adult patients (18 years and older) who have been implanted with a compatible ICM for diagnosis or monitoring of cardiac arrhythmias.
IM007 is intended to be electronically interfaced with other computer systems (remote monitoring platform) that supply the ECG data to IM007 and receive the output of IM007 (analysis) for viewing by the healthcare professionals.
IM007 provides ECG signal analysis to differentiate normal rhythm from abnormalities.
IM007 is not for use in life-supporting or life-sustaining systems or ECG monitors and alarm devices.
IM007 interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and healthcare professionals on an advisory basis only, in conjunction with the clinical knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253463 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253463: ILR ECG Analyzer (IM007).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253463
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026