510(k) · Cleared
ClearediSage Rx (iSage Rx Basal Insulin Titration)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isag Rx, Inc. · NDC Calculator, Drug Dose
Cleared on Mar 7, 2017 after a 243-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Mar 7, 2017
- Review
- 243 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK161865 iSage Rx (iSage Rx Basal Insulin Titration)Isag Rx, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK242066 iSage RxAmalgam Rx, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242066iSage RxAmalgam Rx, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K161865 | iSage Rx (iSage Rx Basal Insulin Titration) | Isag Rx, Inc. | 2017 | — |
| +1 | K242066 | iSage Rx | Amalgam Rx, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K242066 | iSage Rx | 2024 | 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?
- Of its descendants, K242066 (Amalgam Rx, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
iSage Rx™ (iSage Rx Basal Insulin Titration) is software indicated for use by adult patients aged 21 and above who have type 2 diabetes and their healthcare providers to titrate basal insulin. iSage Rx is not intended to replace the care and management provided by a healthcare professional trained in the management of diabetes. iSage Rx should not be used by patients with type 2 diabetes who are also using prandial insulin or patients with type 1 diabetes, gestational diabetes, or patients using an insulin pump.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161865 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161865: iSage Rx (iSage Rx Basal Insulin Titration).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161865
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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