510(k) · Cleared
ClearedT:Slim 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 Oct 31, 2014 as substantially equivalent to K111210 (Tandem Diabetes Care, Inc., 2011) and 1 other predicate after a 123-day review. Its family tree reaches back 7 generations to 1990. 3 of the 20 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Oct 31, 2014
- Review
- 123 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K901588 (1990). 12 ancestors in all. 7 later devices descend from it, 3 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- 6 generations backK960001 Minimed Infusion Pump, Model MMT-507Medtronic Minimed · 1996
- 5 generations backK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
- 4 generations backK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
- 3 generations backK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
- 2 generations backK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)
- 1 generation backK133593 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- This deviceK141758 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK160056 t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK240158 Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK143189 t:flex Insulin Delivery SystemTandem Diabetes Care, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK253534 Pivot Insulin Delivery SystemModular Medical · 2026
- Descendant · cites it directly · 1 of its ownK160482 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016 · cites it directly4descendants
- K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024 · 2 generations on2descendants
- K143189t:flex Insulin Delivery SystemTandem Diabetes Care, Inc. · 2015 · cites it directly2descendants
- K253534Pivot Insulin Delivery SystemModular Medical · 2026 · 3 generations on1descendant
- K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901588 | Minimed (R) Model 506 External Insulin Pump | Medtronic Minimed | 1990 | — |
| −6 | K960001 | Minimed Infusion Pump, Model MMT-507 | Medtronic Minimed | 1996 | — |
| −5 | K013309 | Glucopro Evo Infusion Pump | Nipro Diabetes Systems, Inc. | 2002 | 1 |
| −4 | K050312 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2005 | — |
| −3 | K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2007 | — |
| −2 | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | Class I |
| −1 | K133593 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| 0 (this device) | K141758 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| +1 | K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016 | — |
| +2 | K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | 2024 | — |
| +1 | K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | 2015 | — |
| +3 | K253534 | Pivot Insulin Delivery System | Modular Medical | 2026 | — |
| +1 | K160482 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111210 | T:Slim (TM) 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 (K111210, K133593) Purpose of the 510(k) notification The t:slim® Insulin Delivery System is a modification to the previously cleared t:… | 2011 |
| * | K133593 | T:Slim Insulin Delivery SystemSummary page 4…e Insulin infusion pump Classification Name Infusion Pump per 21 CFR 880.5725 Predicate Devices Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K111210, K133593) Purpose of the 510(k) notification The t:slim® Insulin Delivery System is a modification to the previously cleared t:slim® Ins… | 2014 |
What descends from it? (7)
3 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)
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K990801Minimed 508 Insulin PumpMedtronic Minimed · 1999 · 2 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K042873Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 12 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K160056 (Tandem Diabetes Care, Inc., 2016) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K111210.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 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/K141758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141758: T:Slim 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/K141758
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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