510(k) · Cleared
ClearedPearl Diabetes Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M2 Group Holdings, Inc. · LZG Pump, Infusion, Insulin
Cleared on May 10, 2011 as substantially equivalent to K994186 (Disetronic Medical Systems, 1999) and 2 other predicates after a 435-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.
- Decided
- May 10, 2011
- Review
- 435 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K905693 (1991). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991 · Recalled
- 5 generations backK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · Recalled
- 4 generations backK994186 Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems · 1999
- 3 generations backK021725 Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems AG · 2002
- 2 generations backK022831 Modification to Disetronic D-Tronplus Insulin Infusion PumpDisetronic Medical Systems AG · 2002 · Recalled
- 1 generation backK043000 Modification to D-TronplusDisetronic Medical Systems AG · 2004 · Recalled
- This deviceK100567 Pearl Diabetes Management SystemM2 Group Holdings, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK122483 Pearl Diabetes Management SystemAsante Solutions, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK142619 Snap Insulin Pump SystemAsante Solutions, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K905693 | H-Tron V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1991 | 1 |
| −5 | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1997 | 5 |
| −4 | K994186 | Disetronic D-Tron Insulin Infusion Pump | Disetronic Medical Systems | 1999 | — |
| −3 | K021725 | Disetronic D-Tron Insulin Infusion Pump | Disetronic Medical Systems AG | 2002 | — |
| −2 | K022831 | Modification to Disetronic D-Tronplus Insulin Infusion Pump | Disetronic Medical Systems AG | 2002 | 1 |
| −1 | K043000 | Modification to D-Tronplus | Disetronic Medical Systems AG | 2004 | 2 |
| 0 (this device) | K100567 | Pearl Diabetes Management System | M2 Group Holdings, Inc. | 2011 | — |
| +1 | K122483 | Pearl Diabetes Management System | Asante Solutions, Inc. | 2013 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K994186 | Disetronic D-Tron Insulin Infusion PumpSummary page 1…stablished range of insulin delivery, and uses technology that is substantially equivalent to the identified predicates. a) Disetronic D-TRON and D-TRONplus (K994186, K043000). b) Animas IR1200 (K032257). Intended Use The intended use of the Pearl Diabetes Management System is for… | 1999 |
| * | K043000 | Modification to D-TronplusSummary page 1…d range of insulin delivery, and uses technology that is substantially equivalent to the identified predicates. a) Disetronic D-TRON and D-TRONplus (K994186, K043000). b) Animas IR1200 (K032257). Intended Use The intended use of the Pearl Diabetes Management System is for continuou… | 2004 |
| * | K032257 | Model IR 1200 Insulin PumpSummary page 1…chnology that is substantially equivalent to the identified predicates. a) Disetronic D-TRON and D-TRONplus (K994186, K043000). b) Animas IR1200 (K032257). Intended Use The intended use of the Pearl Diabetes Management System is for continuous, subcutaneous delivery of insulin at p… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122483 | Pearl Diabetes Management System | 2013 | 1 |
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 20 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K122483 (Asante Solutions, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K994186.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
For the 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 as stated in the FDA summary.
https://510kreport.com/device/K100567 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100567: Pearl Diabetes Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100567
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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