510(k) Report

510(k) · Cleared

Cleared

Modification to Medicompass Connect

K091021510(k) TraditionalCleared Jul 15, 200997-day reviewClass II21 CFR 870.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Imetrikus, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Jul 15, 2009 as substantially equivalent to K042768 (Imetrikus, Inc., 2005) and 11 other predicates after a 97-day review. Its family tree reaches back 13 generations to 1987.

Decided
Jul 15, 2009
Review
97 days
Class
Class II
Product code
DRG
Recalls
None
Predicates
12

Its longest line of descent runs back 13 generations to K864318 (1987). 45 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2008: 1 other ancestor2005: 3 other ancestors2004: 4 other ancestors1999: 3 other ancestors2007: 1 other ancestor2006: 5 other ancestors2003: 1 other ancestor2002: 1 other ancestor2001: 3 other ancestors1995: 2 other ancestors1996: 1 other ancestor1979: 1 other ancestor1998: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestor1987: 2 other ancestorsK864318 · The Buddy System/Health Information System · The Buddy Systems, Inc. · 1987K952979 · Hanc Network · Healthtech Services Corp. · 1996K964408 · Poseidon Cardiac Monitoring System (PCMS) · Instromedix, Inc. · 1997K993169 · Modification of: Physiological Signal Transmitter and Receiver, Model 3810A · Hewlett-Packard Co. · 1999K023749 · The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) · Philips Medical Systems · 2002K031840 · Carematix Wellness System · Carematix, Inc. · 2003×2: 2 generations cleared close together, K040966 (2004), K042273 (2004) K050567 · Health Buddy Appliance · Health Hero Network, Inc. · 2005K060843 · Modification to Health Buddy Appliance · Health Hero Network, Inc. · 2006×2: 2 generations cleared close together, K063612 (2006), K070543 (2007) K080091 · Modification to:Health Buddy Appliance · Health Hero Network, Inc. · 200819751980198519901995200020052010
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 11 other ancestors3 generations back: 7 other ancestors4 generations back: 8 other ancestors5 generations back: 1 other ancestor K080091 · Modification to:Health Buddy Appliance · Health Hero Network, Inc. · 2008K070543 · Modification to Health Buddy Appliance · Health Hero Network, Inc. · 2007K063612 · Modification to Health Buddy Appliance · Health Hero Network, Inc. · 2006K060843 · Modification to Health Buddy Appliance · Health Hero Network, Inc. · 2006K050567 · Health Buddy Appliance · Health Hero Network, Inc. · 2005K042273 · Modification to Health Buddy with Device Connectivity · Health Hero Network, Inc. · 2004K040966 · Modification to Carematix Wellness System · Carematix, Inc. · 2004K031840 · Carematix Wellness System · Carematix, Inc. · 2003K023749 · The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) · Philips Medical Systems · 2002K993169 · Modification of: Physiological Signal Transmitter and Receiver, Model 3810A · Hewlett-Packard Co. · 1999K964408 · Poseidon Cardiac Monitoring System (PCMS) · Instromedix, Inc. · 1997K952979 · Hanc Network · Healthtech Services Corp. · 1996K864318 · The Buddy System/Health Information System · The Buddy Systems, Inc. · 1987−10−50
  1. Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
  2. 9 generations between
  3. 3 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
  4. 2 generations backK070543 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2007
  5. 1 generation backK080091 Modification to:Health Buddy ApplianceHealth Hero Network, Inc. · 2008
  6. This deviceK091021 Modification to Medicompass ConnectImetrikus, Inc. · 2009
Show all 13 generations
  1. Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
  2. 12 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
  3. 11 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
  4. 10 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
  5. 9 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
  6. 8 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
  7. 7 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
  8. 6 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
  9. 5 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
  10. 4 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
  11. 3 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
  12. 2 generations backK070543 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2007
  13. 1 generation backK080091 Modification to:Health Buddy ApplianceHealth Hero Network, Inc. · 2008
  14. This deviceK091021 Modification to Medicompass ConnectImetrikus, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K864318The Buddy System/Health Information SystemThe Buddy Systems, Inc.1987—
−12K952979Hanc NetworkHealthtech Services Corp.1996—
−11K964408Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc.1997—
−10K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co.1999—
−9K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems2002—
−8K031840Carematix Wellness SystemCarematix, Inc.2003—
−7K040966Modification to Carematix Wellness SystemCarematix, Inc.2004—
−6K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc.2004—
−5K050567Health Buddy ApplianceHealth Hero Network, Inc.2005—
−4K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc.2006—
−3K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc.2006—
−2K070543Modification to Health Buddy ApplianceHealth Hero Network, Inc.2007—
−1K080091Modification to:Health Buddy ApplianceHealth Hero Network, Inc.2008—
0 (this device)K091021Modification to Medicompass ConnectImetrikus, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198720
198810
199310
199520
199610
199810
199930
200130
200210
200310
200440
200530
200650
200710
200810
200910
FIG. 1 — Lineage of K091021, 1987–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (12)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K042768Medicompass Connect
Summary page 1
…10 DRG Physiological Signal Transmitters and Receivers PREDICATE DEVICES · MediCompass Connect (iMetrikus, Inc): #K042768 * CareMatix Wellness System (CareMatix, Inc.): #K073038, K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Hea…
Imetrikus, Inc.2005—
*K073038Carematix Wellness System, Model CWS-5000.1-B
Summary page 1
…and Receivers PREDICATE DEVICES · MediCompass Connect (iMetrikus, Inc): #K042768 * CareMatix Wellness System (CareMatix, Inc.): #K073038, K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K07054…
Carematix, Inc.2008—
*K040966Modification to Carematix Wellness System
Summary page 1
…and Receivers PREDICATE DEVICES · MediCompass Connect (iMetrikus, Inc): #K042768 * CareMatix Wellness System (CareMatix, Inc.): #K073038, K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K0636…
Carematix, Inc.2004—
*K083331Confidant, Model 2.6
Summary page 1
…CES · MediCompass Connect (iMetrikus, Inc): #K042768 * CareMatix Wellness System (CareMatix, Inc.): #K073038, K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, #K060843, #K050567, #K042273, K040086,…
Confidant, Inc.2009—
*K080091Modification to:Health Buddy Appliance
Summary page 1
…CareMatix Wellness System (CareMatix, Inc.): #K073038, K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, #K060843, #K050567, #K042273, K040086, #K993128) DEVICE DESCRIPTION MediCompass® Connect is a teleh…
Health Hero Network, Inc.2008—
*K070543Modification to Health Buddy Appliance
Summary page 1
…ix Wellness System (CareMatix, Inc.): #K073038, K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, #K060843, #K050567, #K042273, K040086, #K993128) DEVICE DESCRIPTION MediCompass® Connect is a telehealth gate…
Health Hero Network, Inc.2007—
*K063612Modification to Health Buddy Appliance
Summary page 1
…s System (CareMatix, Inc.): #K073038, K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, #K060843, #K050567, #K042273, K040086, #K993128) DEVICE DESCRIPTION MediCompass® Connect is a telehealth gateway to upl…
Health Hero Network, Inc.2006—
*K060843Modification to Health Buddy Appliance
Summary page 1
…ix, Inc.): #K073038, K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, #K060843, #K050567, #K042273, K040086, #K993128) DEVICE DESCRIPTION MediCompass® Connect is a telehealth gateway to upload biometric dat…
Health Hero Network, Inc.2006—
*K050567Health Buddy Appliance
Summary page 1
…#K073038, K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, #K060843, #K050567, #K042273, K040086, #K993128) DEVICE DESCRIPTION MediCompass® Connect is a telehealth gateway to upload biometric data from per…
Health Hero Network, Inc.2005—
*K042273Modification to Health Buddy with Device Connectivity
Summary page 1
…K040966 · Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, #K060843, #K050567, #K042273, K040086, #K993128) DEVICE DESCRIPTION MediCompass® Connect is a telehealth gateway to upload biometric data from personal heal…
Health Hero Network, Inc.2004—
*K040086Health Buddy with Buddylink
Summary page 1
…· Confidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, #K060843, #K050567, #K042273, K040086, #K993128) DEVICE DESCRIPTION MediCompass® Connect is a telehealth gateway to upload biometric data from personal health monito…
Health Hero Network, Inc.2004—
*K993128Healthbuddy with Device Connect [Glucose Meter]
Summary page 1
…fidant 2.6, (Confidant, Inc): #K083331 · Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, #K060843, #K050567, #K042273, K040086, #K993128) DEVICE DESCRIPTION MediCompass® Connect is a telehealth gateway to upload biometric data from personal health monitoring devic…
Health Hero Network, Inc.1999—

Also cleared against K042768: 1 other device →

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 22 years and passes through 8 companies; a new generation was cleared every 11 months on median.
  • 4 of the 45 ancestors have a recall of any class.
  • 1 other device also cites its predicate K042768.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DRG

3in 2025

2007: 62008: 52009: 132010: 102011: 92012: 122013: 132014: 102015: 22016: 22017: 72018: 62019: 52020: 62021: 22022: 62023: 42024: 32025: 32026 (partial year): 2
2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007: 63 days median2008: 74 days median2009: 94 days median2010: 68 days median2011: 104 days median2012: 103 days median2013: 146 days median2014: 177 days median2017: 98 days median2018: 220 days median2019: 122 days median2020: 159 days median2022: 287 days median2023: 212 days median2024: 125 days median2025: 127 days median
2007high 287 (2022) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRG

3in 2007

2007: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRG

52in 2025

2007: 142008: 92009: 52010: 132011: 122012: 92013: 132014: 972015: 1312016: 1822017: 4842018: 1662019: 702020: 822021: 1072022: 432023: 192024: 262025: 52
2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007663314
200857409
2009139405
20101068013
20119104012
20121210309
201313146013
201410177097
20152—0131
20162—0182
20177980484
201862200166
20195122070
20206159082
20212—0107
20226287043
20234212019
20243125026
20253127052
20262—1—

What is it indicated for?

The MediCompass® Connect serves as an interface or a gateway between personal monitoring devices and a general-purpose personal health management database. The MediCompass Connect collects physiologic measurements and retrospectively monitors vital signs from defined personal monitoring devices and transmits the data to a central database server, using standard communication technologies. MediCompass Connect is designed for professional, personal and home use.

MediCompass Connect is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.

Indications for use as stated in the FDA summary.

Also cleared against K042768

1 other device cites the same predicate.

  • K083221Aidera DiasendAidera AB · 2009

More from Imetrikus, Inc.

2 FDA decisions under this applicant name. See the company

  • K042768Medicompass ConnectImetrikus, Inc. · 2005

Recent decisions in DRG

The DRG category page

  • K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc. · 2026
  • K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC · 2026
  • K252440EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025
  • K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025
  • K243837iBSMIorbit Digital Technologies Private Limited · 2025

https://510kreport.com/device/K091021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091021: Modification to Medicompass Connect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091021

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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