510(k) · Cleared
ClearedAidera Diasend System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aidera AB · MRZ Accessories, Pump, Infusion
Cleared on Dec 7, 2010 as substantially equivalent to K083221 (Aidera AB, 2009) and 2 other predicates after a 162-day review. Its family tree reaches back 12 generations to 1987. 2 later devices descend from it.
- Decided
- Dec 7, 2010
- Review
- 162 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K864318 (1987). 40 ancestors in all, the oldest K790130 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations between
- 3 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK063484 Patient Data Handler & Devices (PDH&D)Intermed Advisors, Inc. · 2006
- 1 generation backK083221 Aidera DiasendAidera AB · 2009
- This deviceK101806 Aidera Diasend SystemAidera AB · 2010
- Descendant · cites it directly · 0 of its ownK132618 Onetouch RevealLifescan, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK122361 T:Connect Data Management SystemTandem Diabetes Care, Inc. · 2013
Show all 12 generations
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 11 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 10 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 9 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 8 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 7 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 6 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 5 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 4 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 3 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK063484 Patient Data Handler & Devices (PDH&D)Intermed Advisors, Inc. · 2006
- 1 generation backK083221 Aidera DiasendAidera AB · 2009
- This deviceK101806 Aidera Diasend SystemAidera AB · 2010
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 |
|---|---|---|---|---|---|
| −12 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −11 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −10 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −9 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −8 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −7 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −6 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −5 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −4 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −3 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −2 | K063484 | Patient Data Handler & Devices (PDH&D) | Intermed Advisors, Inc. | 2006 | — |
| −1 | K083221 | Aidera Diasend | Aidera AB | 2009 | — |
| 0 (this device) | K101806 | Aidera Diasend System | Aidera AB | 2010 | — |
| +1 | K132618 | Onetouch Reveal | Lifescan, Inc. | 2013 | — |
| +1 | K122361 | T:Connect Data Management System | Tandem Diabetes Care, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MRZ? 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 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 |
|---|---|---|---|
| * | K083221 | Aidera DiasendSummary page 1…Classification Status: Class 11 according to Sec. 880.2910 and 862.1345 Product Codes: MRZ, NBW 2. Equivalent devices K083221, Aidera AB, Aidera Diasend K072698, Confidant Inc, Confidant 2.5 K032 164, Medtronic Inc, Medtronic Minimed DDMS 3.… | 2009 |
| * | K072698 | Confidant 2.5Summary page 1…Class 11 according to Sec. 880.2910 and 862.1345 Product Codes: MRZ, NBW 2. Equivalent devices K083221, Aidera AB, Aidera Diasend K072698, Confidant Inc, Confidant 2.5 K032 164, Medtronic Inc, Medtronic Minimed DDMS 3. Description of the Device Diasend i… | 2007 |
| * | K032164 | Diabetes Data Management System (DDMS), Model 7333Summary page 1…2.1345 Product Codes: MRZ, NBW 2. Equivalent devices K083221, Aidera AB, Aidera Diasend K072698, Confidant Inc, Confidant 2.5 K032 164, Medtronic Inc, Medtronic Minimed DDMS 3. Description of the Device Diasend is a system for transmitting data from patien… | 2003 |
What descends from it? (2)
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 23 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 4 of the 40 ancestors have a recall of any class.
- Of its descendants, K132618 (Lifescan, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Aidera Diasend is indicated for use by individuals or healthcare professionials in the borne or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101806: Aidera Diasend System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101806
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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