510(k) · Cleared
ClearedSnap Insulin Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asante Solutions, Inc. · LZG Pump, Infusion, Insulin
Cleared on Dec 18, 2014 as substantially equivalent to K122483 (Asante Solutions, Inc., 2013) after a 93-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Dec 18, 2014
- Review
- 93 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K905693 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991 · Recalled
- 7 generations backK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · Recalled
- 6 generations backK994186 Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems · 1999
- 5 generations backK021725 Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems AG · 2002
- 4 generations backK022831 Modification to Disetronic D-Tronplus Insulin Infusion PumpDisetronic Medical Systems AG · 2002 · Recalled
- 3 generations backK043000 Modification to D-TronplusDisetronic Medical Systems AG · 2004 · Recalled
- 2 generations backK100567 Pearl Diabetes Management SystemM2 Group Holdings, Inc. · 2011
- 1 generation backK122483 Pearl Diabetes Management SystemAsante Solutions, Inc. · 2013
- This deviceK142619 Snap Insulin Pump SystemAsante Solutions, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905693 | H-Tron V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1991 | 1 |
| −7 | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1997 | 5 |
| −6 | K994186 | Disetronic D-Tron Insulin Infusion Pump | Disetronic Medical Systems | 1999 | — |
| −5 | K021725 | Disetronic D-Tron Insulin Infusion Pump | Disetronic Medical Systems AG | 2002 | — |
| −4 | K022831 | Modification to Disetronic D-Tronplus Insulin Infusion Pump | Disetronic Medical Systems AG | 2002 | 1 |
| −3 | K043000 | Modification to D-Tronplus | Disetronic Medical Systems AG | 2004 | 2 |
| −2 | K100567 | Pearl Diabetes Management System | M2 Group Holdings, Inc. | 2011 | — |
| −1 | K122483 | Pearl Diabetes Management System | Asante Solutions, Inc. | 2013 | — |
| 0 (this device) | K142619 | Snap Insulin Pump System | Asante Solutions, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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.
Planning a device in LZG? 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 |
|---|---|---|---|
| * | K122483 | Pearl Diabetes Management SystemSummary page 4…ump, Infusion, Insulin Product Code: LZG Regulation Number: 880.5725 Class: II Predicate Device Asante Pearl Diabetes Management System (K122483) Intended Use The Snap Insulin Pump System is intended for continuous, subcutaneous delivery of insulin at programmable basal an… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 9 ancestors have a recall of any class.
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 Asante Snap Insulin Pump System is indicated for continuous, subcutaneous delivery of insulin at programmable
basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.
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/K142619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142619: Snap Insulin Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142619
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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