Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4780](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4780) → OTK — Wound Drain Catheter System

# OTK · Wound Drain Catheter System

_General, Plastic Surgery · 21 CFR 878.4780 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK

## Overview

- **Product Code:** OTK
- **Device Name:** Wound Drain Catheter System
- **Regulation:** [21 CFR 878.4780](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4780)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **3rd-party reviewable:** yes

## Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

## Classification Rationale

Class II.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K203394](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK/K203394.md) | PleuraFlow System with FlowGlide | Clearflow, Inc. | Mar 2, 2021 | SESE |
| [K191733](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK/K191733.md) | The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. | Jul 26, 2019 | SESE |
| [K182067](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK/K182067.md) | PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc. | Aug 14, 2018 | SESE |
| [K163139](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK/K163139.md) | PleuraFlow System with FlowGlide | Clearflow, Inc. | Nov 30, 2016 | SESE |
| [K153681](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK/K153681.md) | PleuraFlow System | Clearflow, Inc. | Jan 20, 2016 | SESE |
| [K150042](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK/K150042.md) | PleuraFlow System | Clearflow, Inc. | Jun 2, 2015 | SESE |
| [K093565](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK/K093565.md) | PLEURAFLOW CATHETER SYSTEM | Clear Catheter Systems | Dec 3, 2010 | SESE |

## Top Applicants

- Clearflow, Inc. — 6 clearances
- Clear Catheter Systems — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OTK)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com