510(k) · Cleared
ClearedGuava II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiocomm Solutions, Inc. · DPS Electrocardiograph
Cleared on Feb 11, 2014 as substantially equivalent to K111320 (Cardiocomm Solutions, Inc., 2011) and 1 other predicate after a 531-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 11, 2014
- Review
- 531 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K941811 (1994). 36 ancestors in all, the oldest K822695 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 6 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 5 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 4 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 3 generations backK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- 2 generations backK083321 Cardio-ViewCurlview Igt, LLC · 2008
- 1 generation backK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- This deviceK122632 Guava IICardiocomm Solutions, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK162571 Bioflux SoftwareBiotricity, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK201040 Bioflux Software IIBiotricity · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −7 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −6 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −5 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −4 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −3 | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| −2 | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| −1 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| 0 (this device) | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
| +1 | K162571 | Bioflux Software | Biotricity, Inc. | 2016 | — |
| +2 | K201040 | Bioflux Software II | Biotricity | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K111320 | GlobalcardioSummary page 3…d scenario validations, algorithm confirmation testing, and device functional testing. Conclusion: The proposed device is substantial equivalent to the GlobalCardio (KI 111320) Monebo Automated EGG Analysis and Interpretation Software Library (K062282) devices. The proposed device has a similar intended… | 2011 |
| * | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Summary page 2…GlobalCardio (KI 11320) Monebo Automated EGG Analysis and Interpretation Software Library (K062282) Guava 11 has the same classification information, the same performance safety, the same design principle, similar intended use… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162571 | Bioflux Software | 2016 | 1 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 36 ancestors have a recall of any class.
- Of its descendants, K162571 (Biotricity, Inc., 2016) has gone furthest, with 1 descendant of its own.
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?
Guava 11 is intended to be used by cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givens to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. Guava Illis intended to be electronically interfaced, and perform analysis with data transferred from other computer…
Read the full statement (225 words)
Guava 11 is intended to be used by cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givens to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. Guava Illis intended to be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems. Guava II includes an algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation. The product also includes an automatic analysis and interpretation software library that provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to twelve (12) leads of historic ambulatory ECG data. The Guava II algorithm analysis can detect and classify arrhythmias and may be used to triage data, however, Guava 11 is not intended to offer independent diagnosis or provide medical alarms. Clinical judgment and experience are used to check and interpret the data as part of a diagnosis. Guava Illis not for use in life-supporting or sustaining systems or EGG monitoring devices. Guava II is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropniate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122632: Guava II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122632
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