510(k) · Cleared
ClearedDigital Routines
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gnc Holdings, LLC · NDC Calculator, Drug Dose
Cleared on Mar 15, 2023 as substantially equivalent to K203434 (Welldoc, Inc., 2021) after a 257-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Mar 15, 2023
- Review
- 257 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K010362 (2001). 25 ancestors in all, the oldest K001907 (2000). No later device cites it as a predicate yet.
- Root · 11 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 7 generations between
- 3 generations backK171450 Glooko Mobile Insulin Dosing SystemGlooko, Inc. · 2018
- 2 generations backK193654 BlueStar RxWelldoc, Inc. · 2020
- 1 generation backK203434 BlueStar RxWelldoc, Inc. · 2021
- This deviceK221924 Digital RoutinesGnc Holdings, LLC · 2023
Show all 11 generations
- Root · 11 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 10 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 9 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 8 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 7 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 6 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 5 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 4 generations backK161433 Insulia Diabetes Management CompanionVoluntis Sa. · 2016
- 3 generations backK171450 Glooko Mobile Insulin Dosing SystemGlooko, Inc. · 2018
- 2 generations backK193654 BlueStar RxWelldoc, Inc. · 2020
- 1 generation backK203434 BlueStar RxWelldoc, Inc. · 2021
- This deviceK221924 Digital RoutinesGnc Holdings, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −10 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −9 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −8 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −7 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −6 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −5 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −4 | K161433 | Insulia Diabetes Management Companion | Voluntis Sa. | 2016 | — |
| −3 | K171450 | Glooko Mobile Insulin Dosing System | Glooko, Inc. | 2018 | — |
| −2 | K193654 | BlueStar Rx | Welldoc, Inc. | 2020 | — |
| −1 | K203434 | BlueStar Rx | Welldoc, Inc. | 2021 | — |
| 0 (this device) | K221924 | Digital Routines | Gnc Holdings, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K203434 | BlueStar RxSummary page 4…Predictive pulmonary-function value calculator Classification: Class II Predicate Device: WellDoc Inc. – BlueStar® Rx (K203434) Device Description: The Digital Routines is a stand-alone medical software system intended to be used by patients aged 21 and o… | 2021 |
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 22 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 25 ancestors have a recall of any class.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Digital Routines is indicated for use by healthcare providers (HCPs) and their patients - aged 21 years and older - who have type 2 diabetes. Digital Routines is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Digital Routines system analyzes and reports blood glucose test results and supports medication adherence. In addition, Digital Routines provides…
Read the full statement (261 words)
Digital Routines is indicated for use by healthcare providers (HCPs) and their patients - aged 21 years and older - who have type 2 diabetes. Digital Routines is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Digital Routines system analyzes and reports blood glucose test results and supports medication adherence. In addition, Digital Routines provides coaching messages (motivational, behavioral, and educational) based on blood glucose values and trends. It includes software intended for use on mobile phones (for patients) or personal computers (for HCPs) in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The following Digital Routines insulin management features are for prescription use only:
• For bolus insulin users with type 2 diabetes, Digital Routines includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value. The healthcare provider must activate the insulin dose calculator for patient.
• For basal insulin users with type 2 diabetes, Digital Routines includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the IAP and configure it with patient-specific parameters.
Digital Routines is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221924: Digital Routines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221924
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