FDA product code OUG: Medical Device Data System
OUG is the FDA product code for medical device data system. It is a Class I device, regulated under 21 CFR 880.6310 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under OUG. The average 510(k) review took 203 days (median 203). FDA has posted 24 recalls for OUG devices, 2 initiated in the last five years.
Definition
A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.
Classification
| Field | Value |
|---|---|
| Device name | Medical Device Data System |
| Device class | Class I |
| Regulation | 21 CFR 880.6310 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OUG clearance
Top OUG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tandem Diabetes Care, Inc. | 1 | 2013-02-22 |
Most recent OUG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122361 | Tandem Diabetes Care, Inc. | T:CONNECT DATA MANAGEMENT SYSTEM | 2013-02-22 | 203 |
Recalls for OUG devices
24 product recalls in 23 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2023-03-08.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code OUG?
OUG is the FDA product code for medical device data system. It is a Class I device, regulated under 21 CFR 880.6310 and reviewed by the General Hospital panel.
What device class is OUG?
Class I, regulation 21 CFR 880.6310. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OUG?
Across 1 cleared submissions the average was 203 days from receipt to decision (median 203).
Which companies have the most OUG clearances?
Tandem Diabetes Care, Inc. (1).
Have OUG devices been recalled?
Yes: 24 product recalls across 23 recall events; the most recent began 2023-03-08.
Next steps
- Run an FDA pathway report with predicate devices for product code OUG
- Run a recall and safety report across every OUG manufacturer
- Watch product code OUG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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