510(k) · Cleared
ClearedMedicompass Connect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imetrikus, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 22, 2005 as substantially equivalent to K040086 (Health Hero Network, Inc., 2004) after a 140-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Feb 22, 2005
- Review
- 140 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950727 (1995). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
- 1 generation backK040086 Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004
- This deviceK042768 Medicompass ConnectImetrikus, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK083221 Aidera DiasendAidera AB · 2009
- Descendant · 2 generations on · 2 of its ownK101806 Aidera Diasend SystemAidera AB · 2010
- Descendant · 3 generations on · 0 of its ownK132618 Onetouch RevealLifescan, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK122361 T:Connect Data Management SystemTandem Diabetes Care, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK091021 Modification to Medicompass ConnectImetrikus, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K083221Aidera DiasendAidera AB · 2009 · cites it directly3descendants
- K101806Aidera Diasend SystemAidera AB · 2010 · 2 generations on2descendants
- K132618Onetouch RevealLifescan, Inc. · 2013 · 3 generations on0descendants
- K122361T:Connect Data Management SystemTandem Diabetes Care, Inc. · 2013 · 3 generations on0descendants
- K091021Modification to Medicompass ConnectImetrikus, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950727 | One Touch Profile Complete Diabetes Tracking System | Lifescan, Inc. | 1995 | — |
| −1 | K040086 | Health Buddy with Buddylink | Health Hero Network, Inc. | 2004 | — |
| 0 (this device) | K042768 | Medicompass Connect | Imetrikus, Inc. | 2005 | — |
| +1 | K083221 | Aidera Diasend | Aidera AB | 2009 | — |
| +2 | K101806 | Aidera Diasend System | Aidera AB | 2010 | — |
| +3 | K132618 | Onetouch Reveal | Lifescan, Inc. | 2013 | — |
| +3 | K122361 | T:Connect Data Management System | Tandem Diabetes Care, Inc. | 2013 | — |
| +1 | K091021 | Modification to Medicompass Connect | Imetrikus, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K040086 | Health Buddy with BuddylinkSummary page 4…Class II. 870.1130. Noninvasive blood pressure measurement system Product Code: DXN Substantial equivalence claimed to: 1 K040086 - Health Buddy' with BuddyLink Description: MediCompass Connect is a system that transmits data from personal monitoring de… | 2004 |
What descends from it? (5)
2 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 10 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K083221 (Aidera AB, 2009) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K040086.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
MediCompass Connect serves as an interface or a gateway between personal monitoring devices and a general purpose personal health management database. Monitoring devices that can interface to the MediCompass Connect include, but are not limited to:
Blood glucose monitor
Blood pressure cuffs
Insulin pumps
Spirometers
Scales
MediCompass Connect is designed for professional healthcare settings and home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042768: 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/K042768
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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