510(k) · Cleared
Recalled · Class I · 2014T:Slim (TM) 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 Nov 9, 2011 as substantially equivalent to K990801 (Medtronic Minimed, 1999) and 1 other predicate after a 194-day review. Its family tree reaches back 5 generations to 1990. 3 of the 20 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Nov 9, 2011
- Review
- 194 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K901588 (1990). 10 ancestors in all. 9 later devices descend from it, 2 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- 4 generations backK960001 Minimed Infusion Pump, Model MMT-507Medtronic Minimed · 1996
- 3 generations backK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
- 2 generations backK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
- 1 generation backK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
- This deviceK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK133593 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK141758 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK160056 t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK240158 Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK143189 t:flex Insulin Delivery SystemTandem Diabetes Care, Inc. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K133593T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014 · cites it directly8descendants
- K141758T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014 · cites it directly7descendants
- K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016 · 2 generations on4descendants
- K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024 · 3 generations on2descendants
- K143189t:flex Insulin Delivery SystemTandem Diabetes Care, Inc. · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901588 | Minimed (R) Model 506 External Insulin Pump | Medtronic Minimed | 1990 | — |
| −4 | K960001 | Minimed Infusion Pump, Model MMT-507 | Medtronic Minimed | 1996 | — |
| −3 | K013309 | Glucopro Evo Infusion Pump | Nipro Diabetes Systems, Inc. | 2002 | 1 |
| −2 | K050312 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2005 | — |
| −1 | K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2007 | — |
| 0 (this device) | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | — |
| +1 | K133593 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| +1 | K141758 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| +2 | K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016 | — |
| +3 | K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | 2024 | — |
| +2 | K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | 2015 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K990801 | Minimed 508 Insulin PumpSummary page 1…gust 3, 2011 Common or Usual Name / Classification Regulation Insulin Pump/ /21 C.F.R. 880.5725 Predicate Devices Medtronic MiniMed's 508 Insulin Pump (K990801) Nipro Diabetes Systems, Inc.'s Amigo Insulin Pump (K071613) Intended Use / Indications for Use The t:SlimTM Ins… | 1999 |
| * | K071613 | Amigo Insulin PumpSummary page 1…Insulin Pump/ /21 C.F.R. 880.5725 Predicate Devices Medtronic MiniMed's 508 Insulin Pump (K990801) Nipro Diabetes Systems, Inc.'s Amigo Insulin Pump (K071613) Intended Use / Indications for Use The t:SlimTM Insulin Delivery System is intended for the subcutaneous delivery of in… | 2007 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 10, 2014 | Class I | Z-0827-2014 | Equipment maintenance | Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event. |
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.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 6 of the 10 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K133593 (Tandem Diabetes Care, Inc., 2014) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K990801.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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:slim Insulin Delivery System is intended 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/K111210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111210: T:Slim (TM) Insulin Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111210
Report an extraction error
Are you the manufacturer?
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