510(k) · Cleared
Clearedt:flex Insulin Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tandem Diabetes Care, Inc. · LZG Pump, Infusion, Insulin
Cleared on Jan 9, 2015 as substantially equivalent to K141758 (Tandem Diabetes Care, Inc., 2014) after a 65-day review. Its family tree reaches back 8 generations to 1990. 3 of the 16 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jan 9, 2015
- Review
- 65 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K901588 (1990). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- 7 generations backK960001 Minimed Infusion Pump, Model MMT-507Medtronic Minimed · 1996
- 6 generations backK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
- 5 generations backK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
- 4 generations backK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
- 3 generations backK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)
- 2 generations backK133593 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- 1 generation backK141758 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- This deviceK143189 t:flex Insulin Delivery SystemTandem Diabetes Care, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK160482 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK162080 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See all- K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. · 2016 · cites it directly1descendant
- K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K901588 | Minimed (R) Model 506 External Insulin Pump | Medtronic Minimed | 1990 | — |
| −7 | K960001 | Minimed Infusion Pump, Model MMT-507 | Medtronic Minimed | 1996 | — |
| −6 | K013309 | Glucopro Evo Infusion Pump | Nipro Diabetes Systems, Inc. | 2002 | 1 |
| −5 | K050312 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2005 | — |
| −4 | K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2007 | — |
| −3 | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | Class I |
| −2 | K133593 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| −1 | K141758 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| 0 (this device) | K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | 2015 | — |
| +1 | K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device… | Tandem Diabetes Care, Inc. | 2016 | — |
| +2 | K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device… | Tandem Diabetes Care, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 1 |
| 2004 | 1 | 1 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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.
3 devices in this family have a Class I recall. 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 LZG device
- #1 K253534 Pivot Insulin Delivery Systemscore 16.8 · 10 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 |
|---|---|---|---|
| * | K141758 | T:Slim Insulin Delivery SystemSummary page 4…Usual Name Insulin infusion pump Classification Name Infusion Pump per 21 CFR 880.5725 Predicate Devices Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K141758) Purpose of the 510(k) notification The t:flexŒ Insulin Delivery System is a modification to the previously cleared t:slim ® In… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | 2016 | 1 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K990801Minimed 508 Insulin PumpMedtronic Minimed · 1999 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K042873Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 13 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K160482 (Tandem Diabetes Care, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K141758.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LZG
116in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZG
1in 2022
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · LZG
12,004in 2025
MAUDE reports naming product code LZG, 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 | 3 | 112 | 1 | 5,110 |
| 2008 | 6 | 129 | 13 | 5,711 |
| 2009 | 2 | — | 2 | 9,471 |
| 2010 | 2 | — | 4 | 10,175 |
| 2011 | 4 | 189 | 2 | 12,858 |
| 2012 | 3 | 73 | 4 | 18,367 |
| 2013 | 2 | — | 3 (1) | 30,059 |
| 2014 | 4 | 123 | 2 (1) | 49,188 |
| 2015 | 1 | — | 2 (2) | 69,136 |
| 2016 | 4 | 116 | 0 | 56,581 |
| 2017 | 1 | — | 0 | 44,472 |
| 2018 | 1 | — | 3 (2) | 32,652 |
| 2019 | 2 | — | 5 | 29,027 |
| 2020 | 0 | — | 0 | 32,588 |
| 2021 | 1 | — | 0 | 31,522 |
| 2022 | 1 | — | 1 (1) | 28,225 |
| 2023 | 1 | — | 0 | 21,972 |
| 2024 | 2 | — | 0 | 18,228 |
| 2025 | 0 | — | 0 | 12,004 |
| 2026 | 2 | — | 2 (2) | — |
What is it indicated for?
The t:flex™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143189 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143189: t:flex Insulin Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143189
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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