OTK
7 FDA 510(k) clearances · Product code
29 daysmedian time to decision
380 days90th percentile
7clearances measured
FDA profile
- Official device name
- Wound Drain Catheter System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PleuraFlow System with FlowGlide (K203394) | Clearflow, Inc. | 2021-03-02 |
| The ZIP Accessory Shuttle for PleuraFlow System (K191733) | Clearflow, Inc. | 2019-07-26 |
| PleuraFlow System with FlowGlide Extra Drainage Length (K182067) | Clearflow, Inc. | 2018-08-14 |
| PleuraFlow System with FlowGlide (K163139) | Clearflow, Inc. | 2016-11-30 |
| PleuraFlow System (K153681) | Clearflow, Inc. | 2016-01-20 |
| PleuraFlow System (K150042) | Clearflow, Inc. | 2015-06-02 |
| PLEURAFLOW CATHETER SYSTEM (K093565) | Clear Catheter Systems | 2010-12-03 |
Track OTK automatically
Every clearance here is in the API, with alerts when new ones post.