510(k) · Cleared
ClearedUpDoc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Updoc, Inc. · NDC Calculator, Drug Dose
Cleared on Dec 23, 2025 as substantially equivalent to K181916 (Hygieia, Inc., 2019) after an 85-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Dec 23, 2025
- Review
- 85 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011571 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK011571 TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp. · 2001
- 2 generations backK082512 Intelligent Dosing System for Insulin-MY Insulin DoserDimensional Dosing Systems, Inc. · 2008
- 1 generation backK181916 d-Nav SystemHygieia, Inc. · 2019
- This deviceK253281 UpDocUpdoc, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011571 | TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite | The RX Files Corp. | 2001 | — |
| −2 | K082512 | Intelligent Dosing System for Insulin-MY Insulin Doser | Dimensional Dosing Systems, Inc. | 2008 | — |
| −1 | K181916 | d-Nav System | Hygieia, Inc. | 2019 | — |
| 0 (this device) | K253281 | UpDoc | Updoc, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K181916 | d-Nav SystemSummary page 5…ATION The UpDoc System is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K181916 d-Nav System / Hygieia, Inc The predicate device has not been subject to a design relate… | 2019 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
UpDoc is a software as a medical device (SaMD) intended to provide medication management for patients aged 18 years and older who have been diagnosed with type 2 diabetes. UpDoc provides patients with insulin treatment plan instructions based on a healthcare provider (HCP)-specified treatment plan. UpDoc contains two user-interactive software components: • Patient User Interface (UpDoc mobile application): Intended for use by patients with type 2…
Read the full statement (186 words)
UpDoc is a software as a medical device (SaMD) intended to provide medication management for patients aged 18 years and older who have been diagnosed with type 2 diabetes.
UpDoc provides patients with insulin treatment plan instructions based on a healthcare provider (HCP)-specified treatment plan.
UpDoc contains two user-interactive software components:
• Patient User Interface (UpDoc mobile application): Intended for use by patients with type 2 diabetes as an aid in optimizing insulin management. Patients use the mobile application to log blood glucose, meal, symptom, and medication adherence data, and receive treatment plan instructions. Data may be entered manually or reported via voice or text-based interactions. The application may also receive blood glucose data via a Bluetooth-enabled glucometer or continuous glucose monitor.
• HCP User Interface (UpDoc web portal): Intended for use by trained healthcare providers to configure and manage the patient-specific insulin treatment plan. This includes insulin dosing instructions (type, starting and maximum doses, adjustment algorithm, and blood glucose targets) and safety protocols to address non-emergency hypoglycemia, hyperglycemia, and related symptoms.
Insulin instructions are computed in UpDoc’s cloud-based application based on the HCP-defined treatment parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253281: UpDoc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253281
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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