510(k) · Cleared
ClearedPivot Insulin Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Modular Medical · LZG Pump, Infusion, Insulin
Cleared on Apr 8, 2026 as substantially equivalent to K240158 (Modular Medical, Inc., 2024) after a 146-day review. Its family tree reaches back 10 generations to 1990. 3 of the 17 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Apr 8, 2026
- Review
- 146 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K901588 (1990). 15 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 17 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 backK160056 t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016
- 1 generation backK240158 Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
- This deviceK253534 Pivot Insulin Delivery SystemModular Medical · 2026
- Descendant · cites it directly · 0 of its ownK262153 Pivot Insulin Delivery SystemModular Medical, Inc. · 2026
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 backK160056 t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016
- 1 generation backK240158 Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
- This deviceK253534 Pivot Insulin Delivery SystemModular Medical · 2026
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K262153Pivot Insulin Delivery SystemModular Medical, Inc. · 2026 · cites it directly0descendants
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 | K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016 | — |
| −1 | K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | 2024 | — |
| 0 (this device) | K253534 | Pivot Insulin Delivery System | Modular Medical | 2026 | — |
| +1 | K262153 | Pivot Insulin Delivery System | Modular Medical, Inc. | 2026 | — |
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 |
|---|---|---|
| 2026 | 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.
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 K262153 Pivot Insulin Delivery Systemscore 14.9 · 11 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 |
|---|---|---|---|
| * | K240158 | Modular Medical MODD1 Insulin Delivery SystemSummary page 5…bmission Type Traditional 510(k) Predicate Device Modular Medical MODD1 Insulin Delivery System (K240158) Date Prepared March 12, 2026 Modular Medical, Inc. Pivot Insulin Delivery System Traditional 510(k)… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262153 | Pivot Insulin Delivery System | 2026 | 0 |
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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K990801Minimed 508 Insulin PumpMedtronic Minimed · 1999 · 5 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K042873Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 2004 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 15 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K262153 (Modular Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Pivot 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 18 years of age and greater.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253534: Pivot 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/K253534
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