510(k) · Cleared
ClearedSimplechoice 3.0 ML Reservoir Pro Reference Number RP-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrx, Inc. · FRN Pump, Infusion
Cleared on Aug 2, 2005 as substantially equivalent to K013767 (Sterling Medivations, Inc., 2001) after a 99-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Aug 2, 2005
- Review
- 99 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991936 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK991936 3.0 ML Reservoir, Model 103/193Medtronic Minimed · 2000
- 1 generation backK013767 Simplicity Infusion Reservoir for Use to Infuse Medicine, Including…Sterling Medivations, Inc. · 2001
- This deviceK051045 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 1 of 1 · See all- K071418Dana 3CC Syringe Insulin ReservoirSooil 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 |
|---|---|---|---|---|---|
| −2 | K991936 | 3.0 ML Reservoir, Model 103/193 | Medtronic Minimed | 2000 | — |
| −1 | K013767 | Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin… | Sterling Medivations, Inc. | 2001 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K013767 | Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an…Summary page 1…ith (770) 242-8723 ext 282 Name of Device: SimpleChoice reservoir Pro Reference Number RP-30 Modified Device: Sterling Medivations Simplicity Infusion Reservoir 510(k) K013767, Marketed as SimpleChoice reservoir Ref erence Number R-30 Description of Device: The SimpleChoice reservoir Pro (3.OmL), Refere… | 2001 |
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 |
|---|---|---|---|
| K071418 | Dana 3CC Syringe Insulin Reservoir | 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K071418 (Sooil Development Co., Ltd., 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013767.
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 SimpleChoice reservoir Pro 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 as stated in the FDA summary.
https://510kreport.com/device/K051045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051045: Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051045
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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