510(k) · Cleared
ClearedGo Dose System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eli Lilly and Company · NDC Calculator, Drug Dose
Cleared on Dec 22, 2016 as substantially equivalent to K082512 (Dimensional Dosing Systems, Inc., 2008) after a 261-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Dec 22, 2016
- Review
- 261 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011571 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011571 | TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite | The RX Files Corp. | 2001 | — |
| −1 | K082512 | Intelligent Dosing System for Insulin-MY Insulin Doser | Dimensional Dosing Systems, Inc. | 2008 | — |
| 0 (this device) | K160949 | Go Dose System | Eli Lilly and Company | 2016 | — |
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 |
|---|---|---|---|
| * | K082512 | Intelligent Dosing System for Insulin-MY Insulin DoserSummary page 6…Additional Product Code: LNX Primary Predicate Device: Intelligent Dosing System For Insulin – my Insulin Doser (K082512) Reference Device: Accu-chek Advisor Insulin Guidance Software (K043529) Device Description The Go Dose Sys… | 2008 |
| † | K043529 | Accu-Chek Advisor Insulin Guidance Software | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K082512.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Go Dose System, comprised of the Go Dose and Go Dose Pro applications, is for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. The Go Dose System is a mobile application for use with iPad or iPhone mobile devices. The Go Dose System provides recommendations for titrating prandial Humalog dosing one meal at a time using blood glucose…
Read the full statement (459 words)
The Go Dose System, comprised of the Go Dose and Go Dose Pro applications, is for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. The Go Dose System is a mobile application for use with iPad or iPhone mobile devices. The Go Dose System provides recommendations for titrating prandial Humalog dosing one meal at a time using blood glucose values entered by the patient. Go Dose and Go Dose Pro applications are not intended to replace the care provided by a licensed health care provider or to provide any diagnosis on patient blood glucose values. Go Dose and Go Dose Pro applications are for prescription use only.
Go Dose is for prescription use only by persons who are:
• Diagnosed with type 2 diabetes mellitus (DM)
• Aged 18-85 years
• Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin
• Requiring treatment intensification with Humalog 100 units per mL (U-100)
• For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate
Go Dose should be used multiple times per day, as directed by your healthcare provider, for entering blood glucose values and getting Humalog dosing recommendations.
The Go Dose daily adjusted dosing algorithm was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.
Go Dose Pro is intended for use by health care providers who have experience prescribing mealtime insulin, including providing direction to patients within the scope of a preplanned treatment program for adjustments to prescribed insulin. Health care providers should use the Go Dose Pro to aid in the review, analysis and evaluation of historical blood glucose test values to support diabetes management in patients that meet the following criteria:
• Diagnosed with type 2 diabetes mellitus (DM)
• Aged 18-85 years
• Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin
• Requiring treatment intensification with Humalog 100 units per mL (U-100)
• For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate
The Go Dose design is based on a dosing algorithm that was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160949: Go Dose System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160949
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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