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, Inc. · LZG Pump, Infusion, Insulin
Cleared on Sep 2, 2026 as substantially equivalent to K253534 (Modular Medical, 2026) after a 68-day review. Its family tree reaches back 11 generations to 1990. 3 of the 17 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 2, 2026
- Review
- 68 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K901588 (1990). 16 ancestors in all. No later device cites it as a predicate yet. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- 7 generations between
- 3 generations backK160056 t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016
- 2 generations backK240158 Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
- 1 generation backK253534 Pivot Insulin Delivery SystemModular Medical · 2026
- This deviceK262153 Pivot Insulin Delivery SystemModular Medical, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- 10 generations backK960001 Minimed Infusion Pump, Model MMT-507Medtronic Minimed · 1996
- 9 generations backK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
- 8 generations backK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
- 7 generations backK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
- 6 generations backK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)
- 5 generations backK133593 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- 4 generations backK141758 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- 3 generations backK160056 t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016
- 2 generations backK240158 Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
- 1 generation backK253534 Pivot Insulin Delivery SystemModular Medical · 2026
- This deviceK262153 Pivot Insulin Delivery SystemModular Medical, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K901588 | Minimed (R) Model 506 External Insulin Pump | Medtronic Minimed | 1990 | — |
| −10 | K960001 | Minimed Infusion Pump, Model MMT-507 | Medtronic Minimed | 1996 | — |
| −9 | K013309 | Glucopro Evo Infusion Pump | Nipro Diabetes Systems, Inc. | 2002 | 1 |
| −8 | K050312 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2005 | — |
| −7 | K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2007 | — |
| −6 | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | Class I |
| −5 | K133593 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| −4 | K141758 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| −3 | K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016 | — |
| −2 | K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | 2024 | — |
| −1 | K253534 | Pivot Insulin Delivery System | Modular Medical | 2026 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K253534 | Pivot Insulin Delivery SystemSummary page 5…n pump Submission Type Traditional 510(k) 510(k) Number K262153 Predicate Device Pivot Insulin Delivery System (K253534) Date Prepared August 25, 2026 Modular Medical, Inc. Pivot Insulin Delivery System Traditional 510(k)… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K990801Minimed 508 Insulin PumpMedtronic Minimed · 1999 · 6 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K042873Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 2004 · 7 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 2.6 years on median.
- 7 of the 16 ancestors have a recall of any class; 3 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. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262153: Pivot 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/K262153
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026