510(k) · Cleared
ClearedMac 1600 Ecg Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DPS Electrocardiograph
Cleared on Jul 15, 2008 as substantially equivalent to K973403 (Marquette Medical Systems, Inc., 1998) and 1 other predicate after a 54-day review. Its family tree reaches back 5 generations to 1991. 5 later devices descend from it.
- Decided
- Jul 15, 2008
- Review
- 54 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903644 (1991). 8 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 4 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 3 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 2 generations backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- 1 generation backK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- This deviceK081437 Mac 1600 Ecg Analysis SystemGe Medical Systems Information Technologies · 2008
- Descendant · cites it directly · 4 of its ownK090212 Mac 800 Resting Ecg Analysis SystemGe Medical Syst. Information Technologies · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK133622 Mac 2000 Ecg Analysis SystemWipro GE Healthcare · 2014
- Descendant · 3 generations on · 0 of its ownK230834 CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK142288 MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK140020 Hyperq Acs-100 SystemBsp-Biiological Signal Processing, Ltd. · 2014
Most influential descendants
Showing 5 of 5 · See all- K090212Mac 800 Resting Ecg Analysis SystemGe Medical Syst. Information Technologies · 2009 · cites it directly4descendants
- K133622Mac 2000 Ecg Analysis SystemWipro GE Healthcare · 2014 · 2 generations on1descendant
- K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd. · 2023 · 3 generations on0descendants
- K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd. · 2014 · 2 generations on0descendants
- K140020Hyperq Acs-100 SystemBsp-Biiological Signal Processing, Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −4 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −3 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −2 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| −1 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| 0 (this device) | K081437 | Mac 1600 Ecg Analysis System | Ge Medical Systems Information Technologies | 2008 | — |
| +1 | K090212 | Mac 800 Resting Ecg Analysis System | Ge Medical Syst. Information Technologies | 2009 | 1 |
| +2 | K133622 | Mac 2000 Ecg Analysis System | Wipro GE Healthcare | 2014 | — |
| +3 | K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | 2023 | — |
| +2 | K142288 | MAC 800 Resting ECG Analysis System | Ge Medical Systems China Co., Ltd. | 2014 | — |
| +2 | K140020 | Hyperq Acs-100 System | Bsp-Biiological Signal Processing, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 3 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K973403 | Cardiosmart STSummary page 2…e 5.2.7 Device/Classification Panel Cardiovascular [per 21 CFR 807.87(c)] 5.2.8 Predicate Device CardioSmart ST V1.3 (K973403) and CASE/Cardiosoft (K031561) 5.2.9 Sterilization Site Not Applicable, device is sold in a non-sterile co… | 1998 |
| * | K031561 | Cardiosoft/Case Cardiac Testing SystemSummary page 2…sification Panel Cardiovascular [per 21 CFR 807.87(c)] 5.2.8 Predicate Device CardioSmart ST V1.3 (K973403) and CASE/Cardiosoft (K031561) 5.2.9 Sterilization Site Not Applicable, device is sold in a non-sterile condition. 5.2.10 Sec… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090212 | Mac 800 Resting Ecg Analysis System | 2009 | 4 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K090212 (Ge Medical Syst. Information Technologies, 2009) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K973403.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 MAC1600 is a portable ECG acquisition, analysis and recording system. The MAC1600 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The basic system shall…
Read the full statement (180 words)
The MAC1600 is a portable ECG acquisition, analysis and recording system. The MAC1600 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode. The basic systems shall print 6 or 12-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. The basic system shall be upgradeable with a third mode of operation: (3) Exercise mode for exercise stress testing. Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional. The arrhythmia detection portion of the MAC 1600 is provided to the customer for the convenience of automatic documentation.
The MAC 1600 is used under the direct supervision of a licensed healthcare practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081437 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081437: Mac 1600 Ecg Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081437
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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