510(k) · Cleared
ClearedDana Diabecare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sooil Development Co., Ltd. · LZG Pump, Infusion, Insulin
Cleared on Aug 14, 2000 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Aug 14, 2000
- Review
- 82 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK001604 Dana DiabecareSooil Development Co., Ltd. · 2000
- Descendant · cites it directly · 1 of its ownK022317 Dana Diabecare II Insulin Pump & Superline-Easyrelease…Sooil Development Co., Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK071418 Dana 3CC Syringe Insulin ReservoirSooil Development Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK063126 Dana Diabecare IisSooil Development Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK013807 Microjet Quark, Model U100 or U40Cane S.R.L. · 2001
Most influential descendants
Showing 4 of 4 · See all- K022317Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-ST, &…Sooil Development Co., Ltd. · 2002 · cites it directly1descendant
- K071418Dana 3CC Syringe Insulin ReservoirSooil Development Co., Ltd. · 2007 · cites it directly0descendants
- K063126Dana Diabecare IisSooil Development Co., Ltd. · 2007 · 2 generations on0descendants
- K013807Microjet Quark, Model U100 or U40Cane S.R.L. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001604 | Dana Diabecare | Sooil Development Co., Ltd. | 2000 | — |
| +1 | K022317 | Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-ST, &… | Sooil Development Co., Ltd. | 2002 | — |
| +1 | K071418 | Dana 3CC Syringe Insulin Reservoir | Sooil Development Co., Ltd. | 2007 | — |
| +2 | K063126 | Dana Diabecare Iis | Sooil Development Co., Ltd. | 2007 | — |
| +1 | K013807 | Microjet Quark, Model U100 or U40 | Cane S.R.L. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K022317 (Sooil Development Co., Ltd., 2002) has gone furthest, with 1 descendant 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) | — |
https://510kreport.com/device/K001604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001604: Dana Diabecare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001604
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026