510(k) · Cleared
Clearedt:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
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 25, 2016 as substantially equivalent to K160482 (Tandem Diabetes Care, Inc., 2016) and 1 other predicate after a 90-day review. Its family tree reaches back 10 generations to 1990. 6 of the 29 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 25, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K901588 (1990). 28 ancestors in all, the oldest K890120 (1989). No later device cites it as a predicate yet. 6 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- 6 generations between
- 3 generations backK141758 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- 2 generations backK143189 t:flex Insulin Delivery SystemTandem Diabetes Care, Inc. · 2015
- 1 generation backK160482 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
- This deviceK162080 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- 9 generations backK960001 Minimed Infusion Pump, Model MMT-507Medtronic Minimed · 1996
- 8 generations backK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
- 7 generations backK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
- 6 generations backK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
- 5 generations backK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)
- 4 generations backK133593 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- 3 generations backK141758 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- 2 generations backK143189 t:flex Insulin Delivery SystemTandem Diabetes Care, Inc. · 2015
- 1 generation backK160482 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
- This deviceK162080 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
Class I recalls in this family
- K111386 Medfusion Model 4000 Syringe Infusion Pump…2 generations back · 2011
- K111210 T:Slim (TM) Insulin Delivery System3 generations back · 2011
- K040899 Medex 3000 Series MR Syringe Infusion Pump3 generations back · 2004
- K023264 Medley Syringe Pump Module System, Model 81103 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K901588 | Minimed (R) Model 506 External Insulin Pump | Medtronic Minimed | 1990 | — |
| −9 | K960001 | Minimed Infusion Pump, Model MMT-507 | Medtronic Minimed | 1996 | — |
| −8 | K013309 | Glucopro Evo Infusion Pump | Nipro Diabetes Systems, Inc. | 2002 | 1 |
| −7 | K050312 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2005 | — |
| −6 | K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2007 | — |
| −5 | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | Class I |
| −4 | K133593 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| −3 | K141758 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 1 |
| 2002 | 1 | 1 |
| 2003 | 1 | 0 |
| 2004 | 2 | 2 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 1 |
| 2016 | 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.
6 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 |
|---|---|---|---|
| * | K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater Our reading of the summary gave K160428, FDA’s number for Certex Spinal Fixation System (X-Spine Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System, t:flex®…”. | 2016 |
| * | K160056 | t:slim Insulin Delivery SystemSummary page 4…elivery System, t:flex® Insulin Delivery System, Tandem Device Updater (K160428) Reference Predicate Device: Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K160056) Purpose of the 510(k) notification The purpose of this 510(k) is to describe modified indications for use of the t:slim® Insul… | 2016 |
| † | K051264 | Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 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.
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 2011 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 16 Class I recalls
- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K990801Minimed 508 Insulin PumpMedtronic Minimed · 1999 · 4 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K042873Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 13 of the 28 ancestors have a recall of any class; 6 have a Class I recall.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 6 years of age and greater. The device is indicated for use with NovoLog® or Humalog® U-100 insulin. The t:flex™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes…
Read the full statement (133 words)
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 6 years of age and greater. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.
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. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.
The Tandem® Device Updater™ System consists of software which allows for communication between a computer and a t:slim® or t:flex™ Insulin Delivery System. It allows for remote software installation and update of a Tandem Insulin Delivery System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162080: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162080
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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