510(k) · Cleared
ClearedT:Connect Data Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tandem Diabetes Care, Inc. · OUG Medical Device Data System
Cleared on Feb 22, 2013 as substantially equivalent to K032164 (Medtronic Minimed, 2003) and 1 other predicate after a 203-day review. Its family tree reaches back 13 generations to 1987.
- Decided
- Feb 22, 2013
- Review
- 203 days
- Class
- Class I
- Product code
- OUG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K864318 (1987). 41 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations between
- 3 generations backK063484 Patient Data Handler & Devices (PDH&D)Intermed Advisors, Inc. · 2006
- 2 generations backK083221 Aidera DiasendAidera AB · 2009
- 1 generation backK101806 Aidera Diasend SystemAidera AB · 2010
- This deviceK122361 T:Connect Data Management SystemTandem Diabetes Care, Inc. · 2013
Show all 13 generations
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 11 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 10 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 9 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 8 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 7 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 6 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 5 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 4 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 3 generations backK063484 Patient Data Handler & Devices (PDH&D)Intermed Advisors, Inc. · 2006
- 2 generations backK083221 Aidera DiasendAidera AB · 2009
- 1 generation backK101806 Aidera Diasend SystemAidera AB · 2010
- This deviceK122361 T:Connect Data Management SystemTandem Diabetes Care, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −12 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −11 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −10 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −9 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −8 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −7 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −6 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −5 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −4 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −3 | K063484 | Patient Data Handler & Devices (PDH&D) | Intermed Advisors, Inc. | 2006 | — |
| −2 | K083221 | Aidera Diasend | Aidera AB | 2009 | — |
| −1 | K101806 | Aidera Diasend System | Aidera AB | 2010 | — |
| 0 (this device) | 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 |
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 OUG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K032164 | Diabetes Data Management System (DDMS), Model 7333Summary page 1…21 C.F.R. 880.5725, Pump, Infusion, Insulin, Class 11,Product Code, LZG. Predicate Devices Medtronic MiniMed Diabetes Data Management System (K032164) Aidera Diasend System (K101806) Intended Use /Indications for Use The t:connect Diabetes Management A… | 2003 |
| * | K101806 | Aidera Diasend SystemSummary page 1…in, Class 11,Product Code, LZG. Predicate Devices Medtronic MiniMed Diabetes Data Management System (K032164) Aidera Diasend System (K101806) Intended Use /Indications for Use The t:connect Diabetes Management Application is intended for use by individ… | 2010 |
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 26 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 4 of the 41 ancestors have a recall of any class.
- 1 other device also cites its predicate K032164.
How does its category compare?
All OUG devicesOUG Medical Device Data System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OUG
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · OUG
Too few OUG 510(k)s in any year since 2007 to give a median.
Recalls per year · OUG
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUG
393in 2025
MAUDE reports naming product code OUG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 7 |
| 2012 | 0 | — | 0 | 23 |
| 2013 | 1 | — | 0 | 21 |
| 2014 | 0 | — | 2 | 24 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 2 | 20 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 414 |
| 2019 | 0 | — | 2 | 46 |
| 2020 | 0 | — | 2 | 29 |
| 2021 | 0 | — | 1 | 79 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 1,249 |
| 2024 | 0 | — | 0 | 554 |
| 2025 | 0 | — | 0 | 393 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The t:connect Diabetes Management Application is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their caregivers, and their healthcare providers in home and clinical settings. The t:connect Application supports diabetes management through the display and analysis of information downloaded from Tandem Diabetes Care insulin pumps and specified blood glucose meters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122361: T:Connect Data Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122361
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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