510(k) · Cleared
ClearedEcg-6 Series Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Instrumentations, Inc. · DPS Electrocardiograph
Cleared on Aug 5, 2011 as substantially equivalent to K090367 (Edan Instruments, Inc., 2009) after a 10-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Aug 5, 2011
- Review
- 10 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K984504 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK984504 Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and AccessoriesNihon Kohden America, Inc. · 1999
- 2 generations backK072217 Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax MNihon Kohden America, Inc. · 2007
- 1 generation backK090367 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2009 · Recalled
- This deviceK112135 Ecg-6 Series ElectrocardiographAdvanced Instrumentations, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984504 | Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and Accessories | Nihon Kohden America, Inc. | 1999 | — |
| −2 | K072217 | Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M | Nihon Kohden America, Inc. | 2007 | — |
| −1 | K090367 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2009 | 1 |
| 0 (this device) | K112135 | Ecg-6 Series Electrocardiograph | Advanced Instrumentations, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K090367 | SE-601 Series ElectrocardiographSummary page 2…, INC Page 1 of 3 . ECG-6 Series Electrocardiograph Predicate Device: SE-601 Series Electrocardiograph K090367 Manufacturer: EDAN Instruments Device Description: ECG-6 series Smart EGG includes three models ECG-6 Pro, ECG-6 Plus a… | 2009 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K090367.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The intended use of the ECG-6 Series Electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted EGG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112135: Ecg-6 Series Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112135
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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