510(k) · Cleared
ClearedIntelligent Dosing System for Insulin-MY Insulin Doser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dimensional Dosing Systems, Inc. · NDC Calculator, Drug Dose
Cleared on Nov 7, 2008 as substantially equivalent to K011571 (The RX Files Corp., 2001) after a 70-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Nov 7, 2008
- Review
- 70 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011571 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK011571 TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp. · 2001
- This deviceK082512 Intelligent Dosing System for Insulin-MY Insulin DoserDimensional Dosing Systems, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK181916 d-Nav SystemHygieia, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK253281 UpDocUpdoc, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK163664 Health-e-Connect System with IDAAlr Technologies · 2017
- Descendant · cites it directly · 0 of its ownK160949 Go Dose SystemEli Lilly and Company · 2016
Most influential descendants
Showing 4 of 4 · See all- K181916d-Nav SystemHygieia, Inc. · 2019 · cites it directly1descendant
- K253281UpDocUpdoc, Inc. · 2025 · 2 generations on0descendants
- K163664Health-e-Connect System with IDAAlr Technologies · 2017 · cites it directly0descendants
- K160949Go Dose SystemEli Lilly and Company · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011571 | TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite | The RX Files Corp. | 2001 | — |
| 0 (this device) | K082512 | Intelligent Dosing System for Insulin-MY Insulin Doser | Dimensional Dosing Systems, Inc. | 2008 | — |
| +1 | K181916 | d-Nav System | Hygieia, Inc. | 2019 | — |
| +2 | K253281 | UpDoc | Updoc, Inc. | 2025 | — |
| +1 | K163664 | Health-e-Connect System with IDA | Alr Technologies | 2017 | — |
| +1 | K160949 | Go Dose System | Eli Lilly and Company | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 NDC? 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 NDC device
- #1 K242775 InPen System App (MMT-8060 (iOS), MMT-8061…score 18.0 · 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 |
|---|---|---|---|
| * | K011571 | TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteSummary page 1…KETED EQUIVALENT DEVICE Company Product 510(k)# RxFiles TRxF Intelligent Dosing System K01 1571 DESCRIPTION OF DEVICE My Insulin Doser/IDS is a next dose calculator for any insulin that can be used by patients with a prescr… | 2001 |
What descends from it? (4)
3 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 NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NDC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDC
60in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDC
299in 2025
MAUDE reports naming product code NDC, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 3 | 118 | 0 | 1 |
| 2015 | 3 | 199 | 0 | 1 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 8 | 189 | 2 | 25 |
| 2018 | 3 | 220 | 1 | 21 |
| 2019 | 1 | — | 1 | 18 |
| 2020 | 5 | 53 | 0 | 10 |
| 2021 | 3 | 269 | 0 | 11 |
| 2022 | 0 | — | 1 | 347 |
| 2023 | 3 | 126 | 0 | 463 |
| 2024 | 3 | 60 | 0 | 168 |
| 2025 | 2 | — | 1 | 299 |
| 2026 | 4 | 90 | 2 | — |
What is it indicated for?
My Insulin Doser/IDS allows a diabetic patient to calculate the best next dose of insulin to achieve a personal glucose target.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082512: Intelligent Dosing System for Insulin-MY Insulin Doser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082512
Report an extraction error
Are you the manufacturer?
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