# K253281: UpDoc

- Pathway: 510(k) (Traditional)
- Applicant: Updoc, Inc.
- Decided: Dec 23, 2025 after 85 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011571 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181916: d-Nav System, Hygieia, Inc. (2019) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K253281
Methodology: https://510kreport.com/methodology