510(k) · Cleared
ClearedAtria 3100, Atria 6100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Science Corporation · DPS Electrocardiograph
Cleared on Apr 19, 2006 as substantially equivalent to K031422 (Philips Medical Systems, 2003) and 1 other predicate after an 86-day review. Its family tree reaches back 4 generations to 1990. 11 later devices descend from it.
- Decided
- Apr 19, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K895520 (1990). 5 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 3 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
- 2 generations backK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
- 1 generation backK050074 12-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005
- This deviceK060167 Atria 3100, Atria 6100Cardiac Science Corporation · 2006
- Descendant · cites it directly · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK171942 ElectrocardiographEdan Instruments, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK170995 ElectrocardiographEdan Instruments, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK212278 ElectrocardiographEdan Instruments, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK222902 Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K160876PC ECGEdan Instruments, Inc. · 2017 · cites it directly8descendants
- K171942ElectrocardiographEdan Instruments, Inc. · 2018 · 2 generations on3descendants
- K170995ElectrocardiographEdan Instruments, Inc. · 2017 · 2 generations on3descendants
- K212278ElectrocardiographEdan Instruments, Inc. · 2022 · 3 generations on2descendants
- K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −3 | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A Series | Philips Medical Systems, Inc. | 2002 | 2 |
| −2 | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models… | Philips Medical Systems | 2003 | — |
| −1 | K050074 | 12-Lead Resting Electrocardiograph, Models CP100 & CP200 | Welch Allyn, Inc. | 2005 | — |
| 0 (this device) | K060167 | Atria 3100, Atria 6100 | Cardiac Science Corporation | 2006 | — |
| +1 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| +2 | K171942 | Electrocardiograph | Edan Instruments, Inc. | 2018 | — |
| +2 | K170995 | Electrocardiograph | Edan Instruments, Inc. | 2017 | — |
| +3 | K212278 | Electrocardiograph | Edan Instruments, Inc. | 2022 | — |
| +4 | K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287…Summary page 1…___ ___ ____ ____ ___ ____ ___ N otification _ _ _ _ PageWriter Trim Series Cardiograph - Phillips Medical K031422 Systemis OP 100 and OP 200 - Welch Allyn, Inc. K-050074 C. Device description… | 2003 |
| * | K050074 | 12-Lead Resting Electrocardiograph, Models CP100 & CP200Summary page 1…Trim Series Cardiograph - Phillips Medical K031422 Systemis OP 100 and OP 200 - Welch Allyn, Inc. K-050074 C. Device description The Atria 3100 and 6100 are 12 lead electrocardiographs designed to record the electric… | 2005 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K160876 (Edan Instruments, Inc., 2017) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K031422.
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?
Under the supervision of a qualified physician trained in EGG interpretation, Atria can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures.
This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient's heart but rather provide an effective beginning for evaluation of adult and pediatric patients with cardiac abnormalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060167: Atria 3100, Atria 6100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060167
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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