510(k) · Cleared
Recalled · Class II · 2015Accu-Chek Spirit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disetronic Medical Systems AG · LZG Pump, Infusion, Insulin
Cleared on Mar 18, 2005 as substantially equivalent to K031390 (Minimed, Inc., 2003) and 1 other predicate after a 150-day review. Its family tree reaches back 1 generation to 2003. 1 of the 42 devices in its family, counting itself, has a Class I recall. 39 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2005
- Review
- 150 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031390 (2003). 2 ancestors in all. 39 later devices descend from it, 1 citing it directly. 1 of the 42 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK031390 Medtronic Minimed Paradigm Insulin Pump, Model MMT-712Minimed, Inc. · 2003 · Recalled
- This deviceK042887 Accu-Chek SpiritDisetronic Medical Systems AG · 2005
- Descendant · cites it directly · 38 of its ownK060876 Accu-Chek Insulin Pump Configuration Software (Standard), Model…Disetronic Medical Systems AG · 2006 · Recalled
- Descendant · 2 generations on · 37 of its ownK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- Descendant · 3 generations on · 33 of its ownK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- Descendant · 4 generations on · 32 of its ownK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 21 of its ownK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology7 generations on · 2020
Most influential descendants
Showing 5 of 39 · See all- K060876Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek…Disetronic Medical Systems AG · 2006 · cites it directly38descendants
- K111353Accu-Check Combo SystemRoche Diagnostics · 2012 · 2 generations on37descendants
- K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · 3 generations on33descendants
- K150910ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · 4 generations on32descendants
- K160629InPenCompanion Medical, Inc. · 2016 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031390 | Medtronic Minimed Paradigm Insulin Pump, Model MMT-712 | Minimed, Inc. | 2003 | 2 |
| 0 (this device) | K042887 | Accu-Chek Spirit | Disetronic Medical Systems AG | 2005 | — |
| +1 | K060876 | Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001… | Disetronic Medical Systems AG | 2006 | 1 |
| +2 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| +3 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| +4 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| +5 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 5 | 1 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K031390 | Medtronic Minimed Paradigm Insulin Pump, Model MMT-712 | 2003 |
| * | K032257 | Model IR 1200 Insulin PumpSummary page 1…n device infusion pumps: * Medtronic MiniMed Paradigm 712 Insulin Pump (K#03 1390) * AnimasJR 1200 Insulin Pump (K#032257) 4) Device The ACCU-CHEK Spirit Insulin Infusion Pump is an external, portable Description insulin pump designed… | 2003 |
What descends from it? (39)
See all 391 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060876 | Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek… | 2006 | 38 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2015 | Class II | Z-1734-2015 | Device Design | Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error… |
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.
- K193483Basal-IQ TechnologyTandem Diabetes Care, Inc. · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K060876 (Disetronic Medical Systems AG, 2006) has gone furthest, with 38 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.
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 ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042887: Accu-Chek Spirit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042887
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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