510(k) · Cleared
ClearedDana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-ST, & Soft-Release-R Infusion Sets
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 2, 2002 as substantially equivalent to K001604 (Sooil Development Co., Ltd., 2000) after a 16-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Aug 2, 2002
- Review
- 16 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001604 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K063126Dana Diabecare IisSooil Development Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001604 | Dana Diabecare | Sooil Development Co., Ltd. | 2000 | — |
| 0 (this device) | K022317 | Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-ST, &… | Sooil Development Co., Ltd. | 2002 | — |
| +1 | K063126 | Dana Diabecare Iis | Sooil Development Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K001604 | Dana Diabecare | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063126 | Dana Diabecare Iis | 2007 | 0 |
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?
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 DANA DiabecareB I1 external programmable syringe infusion pump and the SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets are used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. These devices are not intended for use with blood or blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022317: Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-ST, & Soft-Release-R Infusion Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022317
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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