510(k) · Cleared
ClearedPoseidon Cardiac Monitoring System (PCMS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instromedix, Inc. · DPS Electrocardiograph
Cleared on Jul 23, 1997 as substantially equivalent to K864318 (The Buddy Systems, Inc., 1987) and 2 other predicates after a 261-day review. Its family tree reaches back 2 generations to 1987. 123 later devices descend from it.
- Decided
- Jul 23, 1997
- Review
- 261 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K864318 (1987). 7 ancestors in all. 123 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 1 generation backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- This deviceK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- Descendant · cites it directly · 103 of its ownK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- Descendant · 2 generations on · 98 of its ownK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- Descendant · 2 generations on · 90 of its ownK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- Descendant · 2 generations on · 86 of its ownK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- Descendant · 3 generations on · 59 of its ownK041816 RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004
Showing 5 of 123 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 123 · See all- K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co. · 1999 · cites it directly103descendants
- K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems · 2002 · 2 generations on98descendants
- K031840Carematix Wellness SystemCarematix, Inc. · 2003 · 2 generations on90descendants
- K040966Modification to Carematix Wellness SystemCarematix, Inc. · 2004 · 2 generations on86descendants
- K041816RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004 · 3 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −1 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| 0 (this device) | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| +1 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| +2 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| +2 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| +2 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| +3 | K041816 | RTX3320PSTN Wireless Telehealth Gateway | Rtx Healthcare A/S | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 15 | 0 |
| 2010 | 10 | 0 |
| 2011 | 11 | 0 |
| 2012 | 6 | 0 |
| 2013 | 13 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 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? (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 |
|---|---|---|---|
| * | K864318 | The Buddy System/Health Information SystemSummary page 1…Signs System does not replace physician’s care. The LifeSigns System is substantially equivalent to aspects of the predicate systems, the Cardiac Alliance Buddy System, K864318 and K871748, the Healthtech Service Corporation Home Assisted Nursing Care System, K952979, and has features that are equivalent… | 1987 |
| * | K871748 | The Buddy System W/Optional Ecg ElectrodeSummary page 1…does not replace physician’s care. The LifeSigns System is substantially equivalent to aspects of the predicate systems, the Cardiac Alliance Buddy System, K864318 and K871748, the Healthtech Service Corporation Home Assisted Nursing Care System, K952979, and has features that are equivalent to features… | 1987 |
| * | K952979 | Hanc NetworkSummary page 1…valent to aspects of the predicate systems, the Cardiac Alliance Buddy System, K864318 and K871748, the Healthtech Service Corporation Home Assisted Nursing Care System, K952979, and has features that are equivalent to features found in the predicate devices Mortara Eli 100 12-lead cardiograph, (ref' K9206… | 1996 |
| † | K920627 | Model Eli 100 Electrocardiograph | 1992 |
| † | K925402 | Oscillomate Blood Pressure Monitor-Model 9300 | 1993 |
| † | K942248 | Miniaturized Finger Clip Pulse Oximeter | 1994 |
What descends from it? (123)
See all 1234 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | 1999 | 103 |
| K992478 | Physiological Signal Transmitter and Receiver, Model 3810A | 1999 | 35 |
| K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | 2004 | 15 |
| K993643 | Nexsystem Ambulatory Patient Monitor Model Nex 100 | 1999 | 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 10 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K993169 (Hewlett-Packard Co., 1999) has gone furthest, with 103 descendants of its own.
- 1 other device also cites its predicate K864318.
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?
Monitoring of stable patients, not at high risk for life-threatening arrhythmias, after discharge from hospital stay, such as patients with compensated congestive heart failure, patients whose myocardial infarction is not recent, or patients with a stabilized heart condition following open heart surgery or coronary artery disease Monitoring of patients in out-of-hospital convalescence settings Monitoning of patients by physicians, clinics, or skilled…
Read the full statement (106 words)
Monitoring of stable patients, not at high risk for life-threatening arrhythmias, after discharge from hospital stay, such as patients with compensated congestive heart failure, patients whose myocardial infarction is not recent, or patients with a stabilized heart condition following open heart surgery or coronary artery disease
Monitoring of patients in out-of-hospital convalescence settings
Monitoning of patients by physicians, clinics, or skilled care facilities
Any time a health care professional desires monitoring, measuring or recording of a patient's ECG, SpO₂, and/or blood pressure in an out of hospital residence setting
The device is not intended to sound real time alarms
This device does not replace physician's care
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964408: Poseidon Cardiac Monitoring System (PCMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964408
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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