510(k) · Cleared
ClearedMac 2000 Ecg Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wipro GE Healthcare · DPS Electrocardiograph
Cleared on Jan 23, 2014 as substantially equivalent to K073625 (Ge Healthcare Systems Information Technologies, 2008) and 1 other predicate after a 62-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it.
- Decided
- Jan 23, 2014
- Review
- 62 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921669 (1993). 21 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 deviceK133622 Mac 2000 Ecg Analysis SystemWipro GE Healthcare · 2014
- Descendant · cites it directly · 0 of its ownK230834 CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd. · 2023 · 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) | K133622 | Mac 2000 Ecg Analysis System | Wipro GE Healthcare | 2014 | — |
| +1 | K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 3…ble for sale in United States. MACTM 2000 ECG Analysis System is similar to MAC 5500 Resting ECG Analysis Systems K073625 in the technology of downloading orders and patient demographics froni a central ECG cardiovascular inf… | 2008 |
| * | K090212 | Mac 800 Resting Ecg Analysis SystemSummary page 3…e simtilar technology of exporting ECC reports in PDF and WiFi comnmunication from MAC800 Resting ECG Analysis System K090212. For more on the predicate device comparison refer to section 12 of this 510OK… | 2009 |
| * | — | MAC 1600 ECG Analysis System Named without a submission number |
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 |
|---|---|---|---|
| K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | 2023 | 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 2.5 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K230834 (Trismed Co., Ltd., 2023) 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. 2014, 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 2000 ECG analysis system is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire, analyze, display, and record information for adult and pediatric populations in a hospital, medical professional's facility, clinics, physician's office or outreach centers. NOTE: Pediatric populations are defined as patients between the ages of 0 and 15 years. The MAC 2000…
Read the full statement (155 words)
The MAC 2000 ECG analysis system is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire, analyze, display, and record information for adult and pediatric populations in a hospital, medical professional's facility, clinics, physician's office or outreach centers.
NOTE: Pediatric populations are defined as patients between the ages of 0 and 15 years.
The MAC 2000 ECG analysis system provides the following modes of operation:
* Resting ECG mode
* Arrhythmia mode
* Exercise mode for exercise stress testing (optional)
* RR analysis mode for RR interval analysis (optional)
The basic system prints 6 or 12 leads of ECG and is upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.
Arrhythmia detection is provided for the convenience of automatic documentation.
Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133622: Mac 2000 Ecg Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133622
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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