510(k) · Cleared
ClearedSimplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterling Medivations, Inc. · FRN Pump, Infusion
Cleared on Dec 12, 2001 as substantially equivalent to K991936 (Medtronic Minimed, 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Dec 12, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991936 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991936 3.0 ML Reservoir, Model 103/193Medtronic Minimed · 2000
- This deviceK013767 Simplicity Infusion Reservoir for Use to Infuse Medicine, Including…Sterling Medivations, Inc. · 2001
- Descendant · cites it directly · 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991936 | 3.0 ML Reservoir, Model 103/193 | Medtronic Minimed | 2000 | — |
| 0 (this device) | K013767 | Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin… | Sterling Medivations, Inc. | 2001 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K991936 | 3.0 ML Reservoir, Model 103/193Summary page 1…llowing that apply FRN — Pump infusion. Predicate Device: The predicate device for Sterling’s Simplicity™ Infusion reservoir is the MiniMed 3.0 mi reservoir FDA 510 (k) K991936. Description of the New Device: for the Simplicity™ Infusion reservoir for use with MiniMed pumps. The Simplicity Infusion reser… | 2000 |
What descends from it? (2)
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?
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 intended use of the Simplicity Infusion reservoir is to provide a means to infuse medicine, including insulin, from an external infusion pump. The reservoir is not intended 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/K013767 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013767: Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013767
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026