510(k) · Cleared
ClearedMac 5500 HD, Mac 3500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · DPS Electrocardiograph
Cleared on Apr 29, 2011 as substantially equivalent to K073625 (Ge Healthcare Systems Information Technologies, 2008) after a 91-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it.
- Decided
- Apr 29, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921669 (1993). 12 ancestors in all, the oldest K820885 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 5 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 4 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 3 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 2 generations backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- 1 generation backK073625 Modification to: Mac 5500 Resting Ecg Analysis SystemGe Healthcare Systems Information Technologies · 2008
- This deviceK110266 Mac 5500 HD, Mac 3500Ge Medical Systems Information Technologies, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK152135 Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −6 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −5 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −4 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −3 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −2 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| −1 | K073625 | Modification to: Mac 5500 Resting Ecg Analysis System | Ge Healthcare Systems Information Technologies | 2008 | — |
| 0 (this device) | K110266 | Mac 5500 HD, Mac 3500 | Ge Medical Systems Information Technologies, Inc. | 2011 | — |
| +1 | K152135 | Quantitative Electrocardiographic Detector (QED 2000) | Acme Portable Machines, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K073625 | Modification to: Mac 5500 Resting Ecg Analysis SystemSummary page 1…21 CFR 870.2920 Telephone Electrocardiograph DXH Transmitter and Receiver Predicate Device(s): K073625 MAC 5500 ECG Analysis System Device Description: The MAC 5500 HO and MAC 3500 ECG Analysis Systems are… | 2008 |
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 |
|---|---|---|---|
| K152135 | Quantitative Electrocardiographic Detector (QED 2000) | 2016 | 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 18 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K152135 (Acme Portable Machines, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K073625.
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 MAC 5500 HD ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3.6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolutions signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central…
Read the full statement (182 words)
The MAC 5500 HD ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3.6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolutions signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The MAC5500 HD is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
The MAC 3500 ECG Analysis System is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, including interpretive analysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The MAC 3500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110266: Mac 5500 HD, Mac 3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110266
Report an extraction error
Are you the manufacturer?
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