510(k) · Cleared
ClearedMinimed Com-Station, Hardware-7301; Software-7311
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · LZG Pump, Infusion, Insulin
Cleared on Nov 15, 1999 after a 68-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Nov 15, 1999
- Review
- 68 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK993012 Minimed Com-Station, Hardware-7301; Software-7311Medtronic Minimed · 1999
- Descendant · cites it directly · 1 of its ownK243774 ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations · 2025
- Descendant · 2 generations on · 0 of its ownK252546 VantageTM Lumbar Decompression KitAllevion Medical, LLC · 2026
- Descendant · cites it directly · 0 of its ownK020655 Deltec Insulin Infusion Pump and AccessoriesDeltec, Inc. · 2002 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations · 2025 · cites it directly1descendant
- K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC · 2026 · 2 generations on0descendants
- K020655Deltec Insulin Infusion Pump and AccessoriesDeltec, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993012 | Minimed Com-Station, Hardware-7301; Software-7311 | Medtronic Minimed | 1999 | — |
| +1 | K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025 | — |
| +2 | K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | 2026 | — |
| +1 | K020655 | Deltec Insulin Infusion Pump and Accessories | Deltec, Inc. | 2002 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Disetronic D-Modem Named without a submission number |
What descends from it? (3)
2 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, K243774 (Lesspine Innovations, 2025) 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) | — |
What is it indicated for?
The MiniMed Com-Station Communication System is indicated for use as an accessory to MiniMed infusion pumps (models 507, S07C, and 508), and LifeScan (One Touch) and Roche (Accu-Chek) blood glucose meters to transmit and display data from device memory banks.
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/K993012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993012: Minimed Com-Station, Hardware-7301; Software-7311.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993012
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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