510(k) · Cleared
ClearedPrime Ecg System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Medical Technologies, Inc. · DPS Electrocardiograph
Cleared on Jun 11, 2003 as substantially equivalent to K911139 (Hewlett-Packard Co., 1991) and 1 other predicate after a 149-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Jun 11, 2003
- Review
- 149 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911139 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK911139 Hewlett-Packard Models M1400A, M1402A & M1401AHewlett-Packard Co. · 1991
- 1 generation backK012414 Prime Ecg SystemMeridian Medical Technologies, Inc. · 2002
- This deviceK030104 Prime Ecg SystemMeridian Medical Technologies, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK082312 Prime Ecg System (with Enhanced Diagnostic Algorithm)Heartscape Technologies, Ltd. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082312Prime Ecg System (with Enhanced Diagnostic Algorithm)Heartscape Technologies, Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911139 | Hewlett-Packard Models M1400A, M1402A & M1401A | Hewlett-Packard Co. | 1991 | — |
| −1 | K012414 | Prime Ecg System | Meridian Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K030104 | Prime Ecg System | Meridian Medical Technologies, Inc. | 2003 | — |
| +1 | K082312 | Prime Ecg System (with Enhanced Diagnostic Algorithm) | Heartscape Technologies, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K911139 | Hewlett-Packard Models M1400A, M1402A & M1401ASummary page 1…: July 17,200 1 A. Legally Marketed Predicate Devices The PRIME ECG System is substantially equivalent to the Hewlett Packard M1700A cleared under K911139. Both systems have the same intended use, which is to record electrocardiographical signals. B. Dcvicc Description… | 1991 |
| * | K012414 | Prime Ecg SystemSummary page 1…bstantial Equivalence Summary The PRIME ECG system with diagnostic algorithm is substantially equivalent to the PRIME system cleared under 5 lO(k) K012414. It is also substantially equivalent to marketed ECG system, some of which also contain diagnostic algorith… | 2002 |
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 |
|---|---|---|---|
| K082312 | Prime Ecg System (with Enhanced Diagnostic Algorithm) | 2008 | 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 12 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082312 (Heartscape Technologies, Ltd., 2008) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K911139.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030104 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030104: Prime Ecg System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030104
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