510(k) · Cleared
ClearedIM007
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 Nov 3, 2021 as substantially equivalent to K170568 (Cardiologs Technologies, 2017) after a 252-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Nov 3, 2021
- Review
- 252 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003621 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
- 4 generations backK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
- 3 generations backK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
- 2 generations backK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
- 1 generation backK170568 CardioLogs ECG Analysis PlatformCardiologs Technologies · 2017
- This deviceK210543 IM007Implicity, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK253463 ILR ECG Analyzer (IM007)Implicity, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253463ILR ECG Analyzer (IM007)Implicity, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | 2000 | — |
| −4 | K013717 | Brentwood Real Time ST and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | 2002 | — |
| −3 | K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | 2005 | — |
| −2 | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | 2007 | — |
| −1 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | 2017 | — |
| 0 (this device) | K210543 | IM007 | Implicity, Inc. | 2021 | — |
| +1 | K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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 |
|---|---|---|---|
| * | K170568 | CardioLogs ECG Analysis PlatformSummary page 5…edicate and reference devices for IM007 Insertable Cardiac Monitor ECG Analysis System are: Predicate Device CARDIOLOGS, Inc., CardioLogs ECG Analysis Platform, K170568 Reference Device MEDTRONIC, Inc., Reveal LINQ Insertable Cardiac Monitor, K163460 Table 1 provides device informatio… | 2017 |
| † | K163460 | Reveal LINQ Insertable Cardiac Monitor | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253463 | ILR ECG Analyzer (IM007) | 2026 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K253463 (Implicity, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K170568.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
IMO007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. IMO007 supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the IM007 only supports ECG data from Medtronic ICMs. IMO007 is intended to be electronically interfaced with other computer systems (remote monitoring platform) that supply the ECG data to IM007, and receive…
Read the full statement (161 words)
IMO007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data.
IMO007 supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the IM007 only supports ECG data from Medtronic ICMs.
IMO007 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.
IMO007 provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifact.
IMO007 is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.
IMO007 interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
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/K210543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210543: IM007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210543
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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