FDA product code OTK: Wound Drain Catheter System
OTK is the FDA product code for wound drain catheter system. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under OTK, from 2 different applicants. The average 510(k) review took 103 days (median 29).
Definition
For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
Classification
| Field | Value |
|---|---|
| Device name | Wound Drain Catheter System |
| Device class | Class II |
| Regulation | 21 CFR 878.4780 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OTK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 13 |
| 2019 | 1 | 28 |
| 2021 | 1 | 104 |
Compare with all 510(k) review times · Search every OTK clearance
Top OTK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clearflow, Inc. | 6 | 2021-03-02 |
| Clear Catheter Systems | 1 | 2010-12-03 |
Most recent OTK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203394 | Clearflow, Inc. | PleuraFlow System with FlowGlide | 2021-03-02 | 104 |
| K191733 | Clearflow, Inc. | The ZIP Accessory Shuttle for PleuraFlow System | 2019-07-26 | 28 |
| K182067 | Clearflow, Inc. | PleuraFlow System with FlowGlide Extra Drainage Length | 2018-08-14 | 13 |
| K163139 | Clearflow, Inc. | PleuraFlow System with FlowGlide | 2016-11-30 | 21 |
| K153681 | Clearflow, Inc. | PleuraFlow System | 2016-01-20 | 29 |
Recalls for OTK devices
openFDA lists no recalls for product code OTK.
Frequently asked questions
What is FDA product code OTK?
OTK is the FDA product code for wound drain catheter system. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel.
What device class is OTK?
Class II, regulation 21 CFR 878.4780. Typical premarket route: 510(k).
How long does a 510(k) take for product code OTK?
Across 7 cleared submissions the average was 103 days from receipt to decision (median 29).
Which companies have the most OTK clearances?
Clearflow, Inc. (6); Clear Catheter Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OTK
- Run a recall and safety report across every OTK manufacturer
- Watch product code OTK 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times