510(k) · Cleared
ClearedAidera Diasend
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 Feb 3, 2009 as substantially equivalent to K063484 (Intermed Advisors, Inc., 2006) and 2 other predicates after a 95-day review. Its family tree reaches back 11 generations to 1987. 3 later devices descend from it.
- Decided
- Feb 3, 2009
- Review
- 95 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K864318 (1987). 38 ancestors in all, the oldest K790130 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations between
- 3 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 2 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK063484 Patient Data Handler & Devices (PDH&D)Intermed Advisors, Inc. · 2006
- This deviceK083221 Aidera DiasendAidera AB · 2009
- Descendant · cites it directly · 2 of its ownK101806 Aidera Diasend SystemAidera AB · 2010
- Descendant · 2 generations on · 0 of its ownK132618 Onetouch RevealLifescan, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK122361 T:Connect Data Management SystemTandem Diabetes Care, Inc. · 2013
Show all 11 generations
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 10 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 9 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 8 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 7 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 6 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 5 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 4 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 3 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 2 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK063484 Patient Data Handler & Devices (PDH&D)Intermed Advisors, Inc. · 2006
- This deviceK083221 Aidera DiasendAidera AB · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −10 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −9 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −8 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −7 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −6 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −5 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −4 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −3 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −2 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −1 | K063484 | Patient Data Handler & Devices (PDH&D) | Intermed Advisors, Inc. | 2006 | — |
| 0 (this device) | K083221 | Aidera Diasend | Aidera AB | 2009 | — |
| +1 | K101806 | Aidera Diasend System | Aidera AB | 2010 | — |
| +2 | K132618 | Onetouch Reveal | Lifescan, Inc. | 2013 | — |
| +2 | 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 | 1 | 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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K063484 | Patient Data Handler & Devices (PDH&D)Summary page 1…Classification Status: Class II according to Sec. 880.2910 and 862.1345 Product Codes: MRZ and NBW 2. Equivalent devices K063484, Intermed Advicor Inc, Patient Data Handler & Devices K072698, Confidant Inc. Confidant 2.5 K042768, iMetrikus Inc. Med… | 2006 |
| * | K072698 | Confidant 2.5Summary page 1…0.2910 and 862.1345 Product Codes: MRZ and NBW 2. Equivalent devices K063484, Intermed Advicor Inc, Patient Data Handler & Devices K072698, Confidant Inc. Confidant 2.5 K042768, iMetrikus Inc. MediCompass Connect 3. Description of the Device Diasend is… | 2007 |
| * | K042768 | Medicompass ConnectSummary page 1…MRZ and NBW 2. Equivalent devices K063484, Intermed Advicor Inc, Patient Data Handler & Devices K072698, Confidant Inc. Confidant 2.5 K042768, iMetrikus Inc. MediCompass Connect 3. Description of the Device Diasend is a system for transmitting of data from pati… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101806 | Aidera Diasend System | 2010 | 2 |
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 9 companies; a new generation was cleared every 12 months on median.
- 4 of the 38 ancestors have a recall of any class.
- Of its descendants, K101806 (Aidera AB, 2010) has gone furthest, with 2 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. 2009, 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?
Diasend is intended for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a.server data base.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083221: Aidera Diasend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083221
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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