510(k) · Cleared
Cleared3.0 ML Reservoir, Model 103/193
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · FRN Pump, Infusion
Cleared on Jan 18, 2000 after a 223-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jan 18, 2000
- Review
- 223 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK991936 3.0 ML Reservoir, Model 103/193Medtronic Minimed · 2000
- Descendant · cites it directly · 2 of its ownK024056 Sureset 3.0 ML Reservoir, Model 24-103Applied Diabetes Research, Incorporated · 2003
- Descendant · cites it directly · 2 of its ownK013767 Simplicity Infusion Reservoir for Use to Infuse Medicine, Including…Sterling Medivations, Inc. · 2001
- Descendant · 2 generations on · 1 of its ownK051045 Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30Spectrx, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK071418 Dana 3CC Syringe Insulin ReservoirSooil Development Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK041152 Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir…Applied Diabetes Research, Inc. · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K024056Sureset 3.0 ML Reservoir, Model 24-103Applied Diabetes Research, Incorporated · 2003 · cites it directly2descendants
- K013767Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an…Sterling Medivations, Inc. · 2001 · cites it directly2descendants
- K051045Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30Spectrx, Inc. · 2005 · 2 generations on1descendant
- K071418Dana 3CC Syringe Insulin ReservoirSooil Development Co., Ltd. · 2007 · cites it directly0descendants
- K041152Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332AApplied Diabetes Research, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991936 | 3.0 ML Reservoir, Model 103/193 | Medtronic Minimed | 2000 | — |
| +1 | K024056 | Sureset 3.0 ML Reservoir, Model 24-103 | Applied Diabetes Research, Incorporated | 2003 | — |
| +1 | K013767 | Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin… | Sterling Medivations, Inc. | 2001 | — |
| +2 | K051045 | Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30 | Spectrx, Inc. | 2005 | — |
| +1 | K071418 | Dana 3CC Syringe Insulin Reservoir | Sooil Development Co., Ltd. | 2007 | — |
| +2 | K041152 | Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A | Applied Diabetes Research, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 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 FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | — | Single Use Syringe Model 103 Named without a submission number |
What descends from it? (6)
4 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, K024056 (Applied Diabetes Research, Incorporated, 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The MiniMed 3.0 ml Reservoir Model 103/193 is indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not indicated for use with blood or blood products.
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/K991936 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991936: 3.0 ML Reservoir, Model 103/193.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991936
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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