510(k) · Cleared
ClearedIcp Triagemanager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emergo Europe Consulting BV · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 26, 2012 as substantially equivalent to K103276 (Intel Corporation Digital Health Group, 2011) after a 14-day review. Its family tree reaches back 15 generations to 1987.
- Decided
- Jul 26, 2012
- Review
- 14 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K864318 (1987). 54 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 11 generations between
- 3 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 2 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 1 generation backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- This deviceK122095 Icp TriagemanagerEmergo Europe Consulting BV · 2012
Show all 15 generations
- Root · 15 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 14 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 13 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 12 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 11 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 10 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 9 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 8 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 7 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 6 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 5 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 4 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 3 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 2 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 1 generation backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- This deviceK122095 Icp TriagemanagerEmergo Europe Consulting BV · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −14 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −13 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −12 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −11 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −10 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −9 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −8 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −7 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −6 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −5 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −4 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −3 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| −2 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| −1 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
| 0 (this device) | K122095 | Icp Triagemanager | Emergo Europe Consulting BV | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K103276 | Intel Health GuideSummary page 2…FDA cleared predicate device with regard to indications for use, performance and technological characteristics: 5 10O(k) Number: K103276 Trade Name: Intel Health Guide Express Manufacturer: Intel Corporation… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 10 companies; a new generation was cleared every 12 months on median.
- 6 of the 54 ancestors have a recall of any class.
- 5 other devices also cite its predicate K103276.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Tunstall icp triagemanager software application allows the caregiver to review patient information and to motivate and provide educational information to the patient. The Tunstall icp triagemanager is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. Clinical judgment and experience by a caregiver are required to check and interpret the patient information delivered.…
Read the full statement (113 words)
The Tunstall icp triagemanager software application allows the caregiver to review
patient information and to motivate and provide educational information to the patient.
The Tunstall icp triagemanager is not intended to provide automated treatment
decisions, nor is it to be used as a substitute for a professional healthcare judgment.
Clinical judgment and experience by a caregiver are required to check and interpret the
patient information delivered.
The Tunstall icp triagemanager is not intended for real-time monitoring, is not an alarm
system and may not be used to receive real-time or time-critical data, is not intended for
patients requiring direct medical supervision or emergency intervention, and is not
intended for direct diagnosis or monitoring.
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/K122095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122095: Icp Triagemanager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122095
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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